ITTC - Recommended Procedures and Guidelines
船首破波对兴波阻力系数影响的实验研究
由此可见,在船模实验中，船首破波的初现会引起兴波阻力系数 Cw 骤升；随着傅汝德数 Fr 增大，破波最先在线形尺度大的船模兴波中出现。
4. 理论分析
根据傅汝德定律,几何相似船模组的傅汝德数 Fr 相等时，它们的兴波阻力系数 Cw 必相 等。由三个船模求得的兴波阻力系数 Cw 折线在图 3 中应当重合。实际上它们却不重合，导 致该现象的根本原因除测试分析技术外，有如下两点：
船首破波对兴波阻力系数影响的实验研究
余泽雄 1 桑家军 2
大连海事大学航海学院，辽宁省大连市（116026）
E-mail：qdyzx@
摘 要:根据流体力学中傅汝德（Froude）定律：当两形似船的傅汝德数 Fr 相等时，它们的 兴波阻力系数 Cw 必相等；而利用几何相似船模组进行的大量阻力实验研究却表明，在相同 傅汝德数 Fr 下，它们的兴波阻力系数 Cw 并不相等。实验分析结果与理论之间存在差异的重 要原因之一在于傅汝德定律中没有考虑水的粘性影响[1]。本文通过三条形似船模的破波实验 结果，分析出形似船破波的差异性是导致上述问题的另一个重要原因；然后利用流体边界层 理论，给出破波对兴波阻力系数的影响过程；本文的结论对选取尺寸合适的船模进行阻力测 试有重要的指导意义。 关键词：船模实验，傅汝德数， 破波， 兴波阻力系数
4.1 水的粘性力不相似
Rw = ϕ(ρ, L,υ, g)
(1)
式（1）中有五个有量纲的物理量，取 ρ 、L、υ 三个量为基本量，按照量纲分析法的π
定理可知，式（1）用无量纲参数表示时，无量纲参数的数目减为两个： π1 ， π 2 。
现列出除三个基本量之外的物理量的量纲表达式：
[Rw]=[ ρ ][ L2 ][υ 2 ]
ITTC船模试验导则
(m/s) VA (m) C0.7R (m) D (m) R 3 (kg/m ) ρ (m2/s) υ
ITTC – Recommended Procedures and Guidelines
Testing and Extrapolation Methods Propulsion, Propulsor Open Water Test
2.2
Thrust Coefficient Torque Coefficient
Ducted Propeller TD ρ .n 2 D 4 TP Thrust Coefficient KTP = ρ .n 2 D 4 Total thrust coefficient for a ducted propeller unit KTT = KTP+KTD Duct Thrust Coefficient KTD =
η0 =
JKT 2π K Q
J=
VA nD
Reynolds Number of propeller Based on chord length 0.7 R
C0.7 R V + ( 0.7π nD
2 A
Re =
(
2
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1 2
ν
Definition of Variables (N) (N) (N) (N) (Nm) (rps) T TD TP TT Q n
3.1.2.1 Conventional Propellers The propeller model is to be mounted on a drive shaft. A streamlined nose cap of sufficient length to ensure that the inflow over the propeller hub is parallel to the shaft should be mounted upstream of the propeller model, Fig.1. In the case of a pulling propeller, the
USB Type-C 规范1.2(中文版)
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ICH M4 部分翻译
ICH M4 部分翻译1. 一般原则书写正文和使用表格时，应当留有足够空隙以使文件能够完全打印在A4纸（E.U 和日本）以及“8.5×11”（US）的纸张大小上。
左边距应足够大，以避免在装订时造成信息的遮掩。
正文表格和字体的大小应当使用统一样式和大小，并足够大以便即使在影印后仍清晰可辨。
正文推荐使用Times New Roman, 12号。
每一页都应当进行页码标记。
在每一个板块使用字母缩写和缩略时都应当首先对其进行定义，参考文件的引用都应当与现行版本的Uniform Requirements for Manuscripts Submitted to Biomedical Journals[ICMJE]要求一致。
附录：文件细致度CTD明确了很多章节的标题和序号。
是否应当为所有板块提供一个指南以阐明标题与文件位置以及与这些文件内标题的关系？是否应当提供一个指南以阐述多组文档应在CTD和eCTD哪一位置？作为此定义的一个结果，是否应当有一个指南阐述文件应当如何分页以及在目录中应当包含什么内容？文件的定义文件被定义为按照顺序编码，与其他文件用一个tab进行区分的一系列页数。
对于电子提供，一个文件可以等同于一个档案。
纸质提供的文件细致程度应当与电子提交版的一致，即使纸质版文件被更新为电子版，一些文件细致度的变更也应当同步跟进以便进行文件生命周期内的管理。
在电子提交版中，一个新文档的起点与纸质版相同，文件之间用一个tab区分。
当决定是一个文件还是多个文件更为合适时，应当考虑一旦一个特定的方法被采纳，此方法将用于档案整个生命周期的管理，因文件管理的意图是当信息有所变更时提供替代的文件/文档。
以下的表格描述了在CTD/eCTD中文件/文档应当置于哪个等级上，在每一个点上是单个文件还是多组文件更为合适。
此描述适用于一个完整的CTD/eCTD，但对于部分提交或单个提交，并不完全适用。
注1：对于QOS，可对文件细致度进行选择以便调整产品不同水平的复杂度。
英文简历中常用的动词
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7.5-02-07-02.2(waves)
PREDICTION OF POWER INCREASE INIRREGULAR WAVES FROMMODEL TEST ....................................... 21. PURPOSE OF PROCEDURE .............. 22. INTRODUCTION ................................. 23.SUMMARY OF PREDICTION METHODS ............................................. 43.1 Torque and Revolution Method (QNM) ................................................. 43.2 Thrust and Revolution Method(TNM) ................................................. 43.3 Resistance And Thrust IdentityMethod (RTIM) ................................. 93.4 Self-propulsion test in irregularwaves ................................................. 103.5 Resistance test in irregular waves .. 104. BRIEF DESCRIPTION OF MODEL EXPERIMENTS NECESSARY FOR THE PROCEDURE............................ 10 4.1 Resistance test in regular waves ..... 104.1.1 Procedure in general ................... 104.1.2 The model ................................... 104.1.3 Towing technique ....................... 114.1.4 Test conditions ........................... 114.2 Self-propulsion test in regular waves ........................................................ 114.2.1 Procedure in general ................... 114.2.2 Model preparation ...................... 114.2.3 Testing technique ....................... 114.2.4 Test conditions ........................... 124.3 Tests in irregular waves .................. 125. PARAMETERS TO BE TAKEN INTO ACCOUNT ........................................... 126.VALIDATION ..................................... 136.1 Uncertainty Analysis ....................... 137. REFERENCES (13)Prediction of Power Increase in Irregular Waves from Model Test1.PURPOSE OF PROCEDUREThe purpose of this procedure is to provide guidelines on how to obtain accurate predictions of power increase in irregular waves based on responses curves obtained from routine model tests in regular, irregular waves and in still water.2.INTRODUCTIONFor the purpose of predicting power increase in realistic seas, conducting resistance or self-propulsion tests in irregular waves is the most direct and simplest approach. However this is not in general a satisfactory solution, because the results are less precise than those obtained in regular waves and apply only to the particular wave spectra for which the experiments were carried out. In order to design ships or to analyze the measured data of ships at sea, it is necessary to be able to predict ships’ power performance in various irregular wave conditions. The common approach relates to the application of linear spectral analysis, for which purpose it is necessary to have the basic data on ship’s response amplitude operators in regular waves. In particular, by using these data and the irregular wave spectra, power increase in various kinds of irregular waves can be predicted and evaluated.Several methods have been proposed and are in broad use at various laboratories to predict power increase in irregular waves from response amplitude operators obtained from model tests in regular waves and using basic results from performance tests in still water.The Seakeeping Committee of 25th ITTC made comparison of four methods, and the results obtained for various ships show that three of four methods explained below give almost the same results in the case of full load conditions. (See Figures 1 and 2, 25th ITTC (2008))Figure 1: Power increase in irregular waves,Container ship (FULL)Figure 2: Power increase in irregular waves,VLCC (FULL)The predicted results by these three should also be compared with the measured power increase in irregular wave obtained from theThe above discrepancies and scatter between predicted and measure values are estimated to be due to that1)response amplitude operators in regularwaves may not be proportional to the square of incident wave amplitude, whichFig.5 Revolution increase in irregular wavesis the assumption of linear spectral analysis.2) the accuracy of measurements and analysisof the values in irregular waves may be less than those in regular waves including the effect of the time duration of the measurements in irregular waves.(See section 4.3) However, the amount of data for the above evaluation is limited and further investigation is necessary.3. SUMMARY OF PREDICTION METHODSIn the following sections 3.1 to 3.3, three different methods for prediction of power increase in irregular waves based on regular wave test results, mostly used in model basin’s practice worldwide, are described. Power increase prediction methods from direct irregular wave tests are also described in sections 3.4 and 3.5. Table 1 summarizes successive steps in application of these methods, including brief description of their advantages and disadvantages for each method. 3.1 Torque and Revolution Method(QNM)In this method, model tests in still water and in regular waves are carried out at the ship SPP(Self-Propulsion Point), applyingSFC(Skin Friction Correction) force, andresponse amplitude operators of torque and revolutions in regular waves are obtained. Themean propeller torque increase and revolutionincrease in irregular waves are calculated by equations (1) and (2), at assumption thatpropeller torque increase and revolution increase in regular waves are proportional to the square of the incident wave amplitude:MM 2()2()AQ Q S d δωδωως∞=⋅⋅⋅∫(1) MM 2()2()An n S d δωδωως∞=⋅⋅⋅∫ (2)The mean power increase in irregular waves is then calculated by using these mean torque and revolution increases according by the equation (3):()(){}M SW M SW M SW SW 2.75P Q Q n n Q n πδδδ=⋅++−(3) The mean power increase of the ship in irregular wave, then, is obtained under the assumption that the result in model scale can be simply scaled by λ3.5.The advantage of this method is that only self-propulsion tests in still water and in regular waves are to be conducted, and that consideration of propeller performance is not necessary.3.2 Thrust and Revolution Method (TNM)By this method, preliminary SPT (Self-Propulsion Test) is carried out in still water at the ship SPP, measuring the thrust andrevolutions, and then estimating the wake fraction, (1-w )SW . From the test results in regular waves, analogously to 3.1, the mean thrust increaseand propeller revolution increase in irregular waves are calculated by equations (4) and (5) separately: MM 20()2()AT T S d δωδωως∞=⋅⋅⋅∫ (4)MM 2()2()An n S d δωδωως∞=⋅⋅⋅∫ (5)The assumption is that thrust increase and revolution increase in regular waves are proportional to the square of the incident wave amplitude.The total thrust and propeller revolution in irregular waves are given as the sum of those in still water and mean added values in irregular waves: M SW,M M T T T δ=+ (6)M SW,M M n n n δ=+(7)Once thrust and propeller revolution inirregular waves are obtained as above, the power increase in irregular waves is calculated according to the following procedure using the propeller open chart in still water.First, the thrust coefficient K T is calculated by:M24MTM M M T K n D ρ=⋅⋅ (8)On the K T curve, advance ratio J is obtained: (See Figure 6 (A) and (B))(1)w VJ n D−⋅=⋅(9)At this J value, power coefficient K P is obtained on the K P curve: (See Figure 6(C))()32533321Q PK QK J n D JnQw V D ρρ====−(10)By using this K P value, the power inirregular waves is calculated by: ()332S2217575P P nQ K w V D ππρ==−(11) The mean power increase in irregular wavescan be obtained by subtracting the power in still water:SS SW,S P P P δ=− (12)To apply this method, besides self-propulsion tests in still water and in regularwaves, propeller open water performance data in still water are also necessary, but these tests have basically been conducted previously for predicting power in still water in general. The main assumption of this method is that the propeller characteristics and the self-propulsion factors such as wake fraction factor (1-w ) in assumption seems valid only for mild wave conditions. Further investigation on this issue seems desirable.Fig.6 Propeller Open Chart (TNM)K TK PJ(C)3.3 Resistance And Thrust IdentityMethod (RTIM)resistance and Self-propulsion test at ship SPP and their resultant self-propulsion factors. In regular waves, towing tests are performed for obtaining the response amplitude operator of resistance increase, δR (ω)M /ζA 2. Then the resistance increase in irregular waves δR S for given wave energy spectrum S (ω) is calculated as:MS 20()2()sA R R S d δωδωως∞=⋅⋅⋅∫ (13) where the mean resistance increase in irregularwaves in ship scale δR S is assumed to be given by multiplying the ship scale wave energy spectrum S (ω) in equation (13). Total resistance in irregular waves is calculated by: S SW,S S R R R δ=+ (14) The mean power increase in irregular waves is calculated as follows:S S SW2222S SW 31/(1)(1)T Qp R T t TK J D V w w VJ n D K K Jρ=−=−−==(See Figure 7 (A) to (C))from where, the total power in waves iscalculated as: ()3322752175S P P nQK w V Dππρ==− (15) The mean power increase in irregular wavesis obtained by subtracting the power in stillwater from the above power in irregular waves:SS SW,S P P P δ=− (16)The advantage of this method is that only resistance tests in regular waves are to be conducted, which is easier to perform rather than self-propulsion tests in regular waves. Resistance tests, self-propulsion tests and propeller open test in still water are also necessary to be conducted, but they are principally have been carried out previously for power prediction in still water, as mentioned above.Fig.7 Propeller Open Chart (RTIM)K T /J 2K PJ(A)(C)The most advantage of this method is that it allows consideration of other resistance increase components such as due to wind and manoeuvre, in ship design and/or analysis of the ship performance at sea. For instance, the same procedure is used by ISO 15016 to correct the wave effect on the ship speed trial results.The main assumption of this method is the same as in “Thrust and Revolution Method (TNM)”, which is that the propeller characteristics and the self-propulsion factors such as wake fraction factor (1-w) and thrust deduction factor (1-t) in waves are identical to those in still water.3.4Self-propulsion test in irregular wavesBy conducting self-propulsion test in irregular waves, mean propeller torque and revolution increase in irregular waves, δQ M and δn M, can be obtained directly. The mean power increase will be calculated by equation (3) with the above values and those in still water.3.5Resistance test in irregular wavesMean resistance increase in irregular waves, δR, can be obtained directly by performing resistance test in irregular waves. The mean power increase will be calculated by equations (14) to (16) with the above values δR, self-propulsion factors and propeller open water characteristics.4.BRIEF DESCRIPTION OF MODEL EXPERIMENTS NECESSARY FOR THE PROCEDUREUsually, added resistance (or power increase) in waves is measured in the process of basic seakeeping tests, along with motions and motion related effects. Thus, general recommendations outlined in the ITTC RP&G 7.5-02-07-02.1 “Seakeeping Experiments” hold. Some specific details are described below.4.1Resistance test in regular waves4.1.1Procedure in generalExperimental estimation of added resistance in waves is performed in two steps:a)measurement of still water resistance, R SW,at speeds of interestb)measurement of total resistance in waves,R T, at same speedsBoth measurements give values of resistance force averaged over run time. Then, the added resistance is obtained as a difference between the two measured values:AW T SWR R R=−(17)4.1.2The modelRuns in still water and in waves should be performed using preferably one and the same model at one and the same loading condition and the same model outfit. The model should be equipped with all appendages, fixed rudder and propeller hub, but without propeller. If relative motions are to be measured in the course of testing in waves, the probes should be installed during still water tests as well, at presumption that they do not create additional force in waves. However, in specific cases of multiple probes or massive holders, their influence on added resistance should be specially addressed by duplicate testing with and without probes.4.1.3Towing techniqueTwo methods of towing could be possibly applied:a) Constant thrust (model free to surge)b) Constant speed (surge restricted)It has been proven by Journee (1976) that both methods give compatible results for added resistance and do not influence motion measurements. Application of specific towing technique thus depends on towing apparatus available. In principle, constant thrust method gives more freedom to model motions and less oscillations of instantaneous resistance force about its average, but it requires more complicated construction of towing apparatus. Common techniques for avoiding dynamic oscillations in the resistance force make use of a sub-carriage eider suspended on springs of variable elasticity or towed by a servo-motor with controllable tension, but allowing surge. Constant speed method is easy for realization, as long as the sub-carriage can be firmly attached to the main carriage, thus restricting surge motions, but it results in large oscillations of resistance force and eventual loss of accuracy at instant overshooting of force gauge limits, especially in high waves.4.1.4Test conditionsMeasurement of added resistance in regular waves does not require larger samples than these in case of regular seakeeping (motion) experiments and is thus performed within one test run (20 – 25 encounters).4.2Self-propulsion test in regular wavesText body: You have to use ITTC-TB style to obtain this format; you have to use ITTC-TB style to obtain this format, you have to use ITTC-TB style to obtain this format, you haveto use ITTC-TB style to obtain this format, you have to use ITTC-TB style to obtain this format.4.2.1Procedure in generalAnalogously to 4.1.1, the procedure consists of two sets of runs, as follows:a)estimation of self-propulsion point(RPM, torque, thrust or power) in stillwater at certain speedb)estimation of corresponding self-propulsion point in wavesThen the increase in propulsive characteristics (added RPM, added torque, added thrust or power increase) are obtained asa difference between average values measuredin still water and in waves.4.2.2Model preparationPrinciples for model preparation correspondto those outlined in 4.1.2, but drive engine and propeller are installed in addition. If the modelis autonomous (see 4.2.3), rudder control machine must be installed as well.4.2.3Testing techniqueTwo techniques for model guidance are commonly applied:a)captive model (model connected to carriageby a force gauge, zero force correspond tothe self-propulsion point). Several runs atvarious RPM are to be performed to getSPP at any speed of interest, speed beingcontrolled by the towing carriage.b)free-running (autonomous, radio-controlled)model. Several runs at various RPM are tobe performed to get SPP at any speed ofinterest, average speed being controlled by atracking system.It should be noted that both methods are accurate enough approximation to real ship operation condition, where both RPM and speed vary even slightly within one wave period (i.e. Grande et. al., (1992)). Principally it could be modelled by application of special engine controllers but the effect on accuracy will be minor, confronted against complication of experimental set-up.Selection of target self-propulsion point regime depends on adopted method for power prediction as described in para. 3, Table 1 respectively. In case of modelling at ship SPP, additional force to account for skin-friction effects must be applied both in still water and waves, at presumption that the average friction per wave period remains equal to the friction in still water. This force is considered steady and can be applied by additional weights or, more correctly, by a fan installed on-board model. In a similar way, other steady forces, like wind forces on superstructure, can be modelled.4.2.4Test conditions3-4 successive runs at various RPM are required at average to access the SPP at certain speed of advance. In case of a captive model the transition time is shorter and measurement could be completed within a single run. Transition time for free-running models is larger and it may take more runs until steady motion regime is reached.4.3Tests in irregular wavesThere is no practical difference in performing resistance tests or self-propulsion tests in regular or irregular seas, except the time duration of experiment.It is a common practice to collect resistance data in parallel with seakeeping (motions) tests. Statistics set a minimum limit of 20-30 minutes full scale for a representative sample for motions. Considering added resistance (power) as a second-order force, however, some resent studies (i.e. Naito & Kihara (1993) and Kim&Kim, (2010)) arrived at a time span of 1-1,5 hours necessary to ensure convergence of resistance estimates. Repetitive runs are normally conducted to accumulate necessary full scale run duration.5.PARAMETERS TO BE TAKEN INTO ACCOUNTD Propeller diameterQ SW Propeller Torque in still watern SW Propeller revolution in still waterT SW Thrust in still waterR SW Resistance in still waterw Wake fractiont Thrust deduction ratioζАRegular wave amplitudeωWave frequencyS(ω) Wave energy spectrumH W1/3Significant wave heightT0Zero-up-crossing wave periodQ(ω) Propeller Torque in regular wavesn(ω) Propeller revolution in regular wavesT(ω) Thrust in regular wavesR(ω) Resistance in regular wavesδQ(ω) Propeller Torque increase in regular wavesδn(ω) Propeller revolution increase in regular wavesδT(ω) Thrust increase in regular wavesδR(ω) Resistance increase in regular wavesδQ Mean propeller torque increase in irregular seasδn Mean propeller revolution increase in irregular seasδT Mean thrust increase in irregular seasδR Mean resistance increase in irregular seasδP Mean power increase in irregular seas λModel scaleSubscript:Sship scaleMmodel scaleSWstill waterAbbreviations:POC Propeller Open Water CharacteristicRT Resistance TestSPT Self-Propulsion TestSPP Self-Propulsion PointSFC Skin Friction CorrectionRAO Response Amplitude Operator6.VALIDATION6.1Uncertainty AnalysisUncertainty analysis of methods outlined above has to be done, following ITTC Recommended Procedure 7.5-02-02-02 – Uncertainty Analysis, Example for Resistance Test, Revision 2000 7.REFERENCESGrande G., Iannone L. and Penna R., 1992, “INSEAN Standardization Contribution for Seakeeping Model Testing and Data Analysis”, ATMA 96 sessionISO15016:2002, “Ships and marine technology. Guidelines for the assessment of speed and power performance by analysis of speed trial data”ITTC25 Proceedings, seakeeping committee, 2008ITTC26 Proceedings, seakeeping committee, 2011Journee, J.M.J., 1976, “Motions, Resistance and Propulsion of a Ship in Regular Head Waves”, DUT-SHL Report 0428Kim, K.H. and Kim, Y., 2010, “ Numerical Analysis on Added Resistance of Ships”, ISOPE2010Naito S. and Kihara H., 1993, “ Mutual Relation between Record Length and Accuracy of Measuring Data in Irregular Waves”, J SNAJ, Vol. 174Nakamura, S., et al. , 1975, “Propulsive Performance of a Container Ship in Waves”, Kansai Society of Naval Architects (Japanese) Takahashi, T., 1987, “A Practical Prediction Method of Added Resistance of a Ship in Waves and the Direction of its Application to Hull Form Design”, Seibu Society of Naval Architects (Japanese)。
WHO第961号技术报告-附件7-药物生产技术转移指南(中英文)
WHO第961号技术报告附件7 药物生产技术转移指南（中英文1/4）2013-09-29 14:16：27| 分类：WHO|字号订阅World Health OrganizationWHO Technical Report Series, No。
961，2011WHO第961号技术报告附件7 药物生产技术转移指南Annex 7 附件7WHO guidelines on transfer of technology in pharmaceuticalmanufacturingWHO药物生产技术转移指南1。
Introduction 介绍2. Scope 范围3。
Glossary 术语4. Organization and management 组织和管理5. Production：transfer （processing，packaging and cleaning）生产：转移（工艺、包装和清洁）6. Quality control: analytical method transfer质量控制：分析方法转移7. Premises and equipment 厂房设施和设备8. Documentation 文件9。
Qualification and validation 确认和验证References 参考文献1。
Introduction 介绍These guiding principles on transfer of technology are intended to serve as a framework which can be applied in a flexible manner rather than as strict rigid guidance. Focus has been placed on the quality aspects, in line with WHO’s mandate.本指南中关于技术转移的原则意在作为一个框架，以不同方式应用，而不是一个需要严格遵守的指南。
启动临床试验的文件要求
启动临床试验的文件要求英文回答：Starting a clinical trial requires careful planning and adherence to specific requirements. These requirements ensure the safety and efficacy of the trial and protect the rights and well-being of the participants. In this response, I will outline some of the key documents and steps involved in initiating a clinical trial.1. Protocol Development: The first step in starting a clinical trial is the development of a detailed protocol. This document outlines the objectives, methodology, participant eligibility criteria, treatment plans, and data collection procedures for the trial. The protocol serves as a blueprint for the entire study and provides guidance to the research team.2. Informed Consent Forms: Informed consent is acrucial aspect of any clinical trial. Participants mustfully understand the purpose, risks, benefits, andpotential outcomes of the trial before providing their consent to participate. Informed consent forms are written documents that explain these details to participants. They should be clear, concise, and written in a language that participants can easily understand.3. Investigator's Brochure: The investigator's brochure is a comprehensive document that provides essential information about the investigational product being studied. It includes details about the product's composition, pharmacokinetics, pharmacodynamics, and safety profile. The investigator's brochure helps the research team understand the product and its potential effects on participants.4. Institutional Review Board (IRB) Approval: Before initiating a clinical trial, researchers must obtain approval from an IRB. The IRB is an independent committee responsible for reviewing and approving the study protocol and ensuring that the trial meets ethical and regulatory standards. The IRB evaluates the trial's risks and benefits, participant recruitment methods, informed consent process,and data collection procedures.5. Site Selection and Training: Once the necessary approvals are obtained, researchers must identify suitable clinical trial sites. These sites should have the infrastructure, resources, and expertise required to conduct the trial effectively. The research team then provides training to the site staff, including investigators, nurses, and coordinators, to ensure they understand the trial procedures and protocols.6. Recruitment and Enrollment: Participant recruitment is a critical phase of a clinical trial. Researchers use various strategies, such as advertising, physician referrals, and patient databases, to identify potential participants. Once individuals express interest in participating, they undergo screening to determine their eligibility. Eligible participants are then enrolled in the trial, and their informed consent is obtained.7. Data Collection and Analysis: Throughout the trial, data is collected according to the protocol's guidelines.This includes recording participant demographics, medical history, treatment administration, and any adverse events. The collected data is then analyzed using statistical methods to assess the trial's outcomes and determine the safety and efficacy of the investigational product.中文回答：启动临床试验需要仔细的规划和遵守特定的要求。
WHO《数据完整性指南》-2021（中英文对照版）
WHO《数据完整性指南》-2021（中英文对照版）3月29日，WHO发布了第55 届药物制剂规范专家委员会（ECSPP）技术报告TRS No.1033，其中包含新的《数据完整性指南》，翻译如下，分享给大家！Guideline on data integrity数据完整性指南1. Introduction and background介绍和背景1.1. In recent years, the number ofobservations made regarding the integrity of data, documentation and recordmanagement practices during inspections of good manufacturing practice (GMP) (2),good clinical practice (GCP), good laboratory practice (GLP) and Good Trade andDistribution Practices (GTDP) have been increasing. The possible causes forthis may include近年来，在对良好生产规范(GMP)(2)、良好临床规范(GCP)、良好实验室规范(GLP)和良好贸易和分销规范(GTDP)的检查过程中，对数据完整性、文件和记录管理规范的缺陷数量持续增加。
可能的原因包括：(ⅰ) reliance on inadequate human practices;依赖于不适当的人员操作;(ⅱ)poorly defined procedures;规定糟糕的规程(ⅲ)resource constraints;资源限制(ⅳ) the use of computerized systems that are not capable of meetingregulatory requirements or are inappropriately managed and validated (3, 4);使用不满足法规要求，或管理/验证不当的计算机系统(3,4);(ⅴ) in appropriate and inadequate control of data flow; and 不适当和不充分的数据流控制;和(ⅵ)failure to adequately review and manage original data and records.未能充分审核和管理原始数据和记录。
美国DMF目录及要求
Drug SubstanceChemistry, Manufacturing, and Controls InformationDRAFT GUIDANCEThis guidance document is being distributed for comment purposes only. Comments and suggestions regarding this draft document should be submitted within 180 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. Submit comments to Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number listed in the notice of availability that publishes in the Federal Register.For questions regarding this draft document contact (CDER) Stephen Miller (301) 827-2392, (CBER) Chris Joneckis (301) 435-5681, or (CVM) Dennis Bensley (301) 827-6956.U.S. Department of Health and Human ServicesFood and Drug AdministrationCenter for Drug Evaluation and Research (CDER)Center for Biologics Evaluation and Review (CBER)Center for Veterinary Medicine (CVM)January 2004CMCDrug Substance Chemistry, Manufacturing, and Controls InformationAdditional copies are available from:Office of Training and CommunicationDivision of Drug Information, HFD-240Center for Drug Evaluation and ResearchFood and Drug Administration5600 Fishers LaneRockville, MD 20857(Tel) 301-827-4573/cder/guidance/index.htmorOffice of Communication, Training andManufacturers Assistance, HFM-40Center for Biologics Evaluation and ResearchFood and Drug Administration1401 Rockville Pike, Rockville, MD 20852-1448/cber/guidelines.htm.(Tel) Voice Information System at 800-835-4709 or 301-827-1800orCommunications Staff, HFV-12Center for Veterinary MedicineFood and Drug Administration7519 Standish PlaceRockville, MD 20855(Tel) 301-827-3800/cvm/guidanc/published.htmU.S. Department of Health and Human ServicesFood and Drug AdministrationCenter for Drug Evaluation and Research (CDER)Center for Biologics Evaluation and Review (CBER)Center for Veterinary Medicine (CVM)January 2004CMCTABLE OF CONTENTS1I. INTRODUCTION (1)II. BACKGROUND (3)A. The Common Technical Document — Quality (CTD-Q) Format (3)B. Content of an Application (4)C. Additional Guidance (4)D. References to Other Applications or Master Files (MFs) (5)1. Other Applications (5)2. Master Files (MFs) (6)III. GENERAL INFORMATION (S.1) (8)A. Nomenclature (S.1.1) (8)B. Structure (S.1.2) (8)C. General Properties (S.1.3) (9)IV. MANUFACTURE (S.2) (10)A. Manufacturers (S.2.1) (10)B. Description of Manufacturing Process and Process Controls (S.2.2) (10)1. Flow Diagram (11)2. Description of the Manufacturing Process and Process Controls (12)3. Reprocessing, Reworking, Recycling, Regeneration, and Other Operations (15)C. Control of Materials (S.2.3) (18)1. Starting Materials (18)2. Reagents, Solvents, and Auxiliary Materials (19)3. Diluents (20)D. Controls of Critical Steps and Intermediates (S.2.4) (20)E. Process Validation and/or Evaluation (S.2.5) (23)F. Manufacturing Process Development (S.2.6) (23)V. CHARACTERIZATION (S.3) (24)A. Elucidation of Structure and Other Characteristics (S.3.1) (24)1. Elucidation of Structure (24)2. Physicochemical Characterization (25)3. Biological and Other Relevant Characteristics (26)B. Impurities (S.3.2) (27)VI. CONTROL OF DRUG SUBSTANCE (S.4) (29)1 Alphanumeric designations in parentheses that follow headings show where information should be placed in applications that are submitted in Common Technical Document (CTD) format.A. Specification (S.4.1) (29)B. Analytical Procedures (S.4.2) (34)C. Validation of Analytical Procedures (S.4.3) (35)D. Batch Analyses (S.4.4) (35)1. Batch Analysis Reports (36)2. Collated Batch Analyses Data (36)E. Justification of Specification (S.4.5) (37)VII. REFERENCE STANDARDS OR MATERIALS (S.5) (40)VIII. CONTAINER CLOSURE SYSTEM (S.6) (40)IX. STABILITY (S.7) (41)A. Stability Summary and Conclusions (S.7.1) (41)B. Postapproval Stability Protocol and Stability Commitment (S.7.2) (41)C. Stability Data (S.7.3) (41)1. Primary Stability Studies (41)2. Supporting Stability Studies (42)3. Stress Studies (42)X. APPENDICES (A) (43)A. Facilities and Equipment (A.1) (43)B. Adventitious Agents Safety Evaluation (A.2) (44)1. Nonviral Adventitious Agents (45)2. Viral Adventitious Agents (45)XI. REGIONAL INFORMATION (R) (46)A. Executed Production Records (R.1.S) (46)B. Comparability Protocols (R.2.S) (46)C. Methods Validation Package (R.3.S) (46)XII. LITERATURE REFERENCES (3.3) (47)ATTACHMENT 1: (48)STARTING MATERIALS FOR SYNTHETIC DRUG SUBSTANCES (48)ATTACHMENT 2: (56)STARTING MATERIALS OF PLANT OR ANIMAL ORIGIN (56)GLOSSARY (59)GUIDANCE FOR INDUSTRY2Drug SubstanceChemistry, Manufacturing, and Controls Information12345678910111213If you plan to submit comments on this draft guidance, to expedite FDA review of your14comments, please:15∙Clearly explain each issue/concern and, when appropriate, include a proposed revision and the rationale and/or justification for the proposed revision.1617∙Identify specific comments by line numbers; use the pdf version of the document whenever 18possible.19∙If possible, e-mail an electronic copy (Word) of the comments you have submitted to the20docket to cummingsd@.212223I. INTRODUCTION2425Information on the chemistry, manufacturing, and controls (CMC) for the drug substance must 26be submitted to support the approval of original new drug applications (NDAs), abbreviated new 27drug applications (ANDAs), new animal drug applications (NADAs), and abbreviated new28animal drug applications (ANADAs).3 This guidance provides recommendations on the CMC 29information for drug substances that should be submitted to support these applications. The30guidance is structured to facilitate the preparation of applications submitted in Common31Technical Document (CTD) format.3233This guidance addresses the information to be submitted for drug substances to ensure continued 34drug substance and drug product quality (i.e., the identity, strength, quality, purity, and potency).2 This guidance has been prepared by Drug Substance Technical Subcommittee of the Chemistry Manufacturing andControls Coordinating Committee (CMC CC) in the Center for Drug Evaluation and Research (CDER), the Center for Biologics Evaluations and Research (CBER) and the Center for Veterinary Medicine (CVM) at the FDA.3 See 21 CFR 314.50(d)(1) and 514.1(b)This guidance provides recommendations on the information that should be included for the3536following topics:37∙Nomenclature, structure, and general drug substance properties3839∙Manufacture40∙Characterization41∙Control of drug substance42∙Reference standards or materials43∙Container closure system44∙Stability45The recommendations provided in this guidance apply to the following types of drug substances:464748∙Drug substances manufactured by chemical synthesis49∙Highly purified and well characterized drug substances derived from plants or animals 4 50∙Semisynthetic drug substances manufactured by the chemical modification of a highly 51purified and well characterized intermediate derived from plants or animals52∙The synthetic portion of the manufacturing process for semisynthetic drug substances53manufactured by the chemical modification of an intermediate produced by conventional 54fermentation.5556The guidance does not provide specific recommendations relating to the following:5758∙Monoclonal antibodies59∙Peptides60∙Oligonucleotides61∙Radiopharmaceuticals62∙Medical gases63∙Drug substances that are not well characterized (e.g., botanicals, some proteins) derived 64from plants or animals65∙Drug substances derived using transgenic technology66∙Drug substances derived directly from or manufacturing operations involving67fermentation (conventional fermentation or using rDNA technology) or tissue or cell68culture.6970More detailed guidance on the content of an application may be available in separate guidance 71documents for specific types of drug substances (see section II.C). Applicants with drug72substances not specifically covered by this (Drug Substance guidance) or another guidance can 73apply the content recommendations in this guidance, as scientifically appropriate, and/or can74contact the appropriate chemistry review teams for guidance.754 For purposes of this guidance, d rug substances derived from plants or animals does not include materials producedby plant cell fermentation, animal cell or tissue culture, or through use of transgenic technology (e.g.,biotechnology-derived protein drug products).FDA’s guidance docume nts, including this guidance, do not establish legally enforceable7677responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should 78be viewed only as recommendations, unless specific regulatory or statutory requirements arecited. The use of the word should in Agency guidances means that something is suggested or7980recommended, but not required.8182This guidance, when finalized, will replace the guidance entitled Submitting Supporting83Documentation in Drug Applications for the Manufacture of Drug Substances (February 1987).848586II. BACKGROUND8788A. The Common Technical Document — Quality (CTD-Q) Format89In November 2000, the International Conference on Harmonisation of Technical9091Requirements for Registration of Pharmaceuticals for Human Use (ICH) issued92harmonized guidance for the format of drug product applications (i.e., Common93Technical Document (CTD)). The CTD describes a format for applications that94(supplemented with regional information) can be used for submission to the regulatory 95authorities in the United States, European Union, and Japan. One focus of this effort was 96harmonizing the format for quality information (i.e., chemistry, manufacturing, and97controls) that will be submitted in an application. FDA’s guidance on M4Q: The CTD —98Quality describes the format for the quality information submitted in Module 3 of an99application and provides additional information on formatting aspects of an application. 100Applicants can submit NDAs, ANDAs, NADAs, and ANADAs using the CTD-Q101format.5Applicants should review FDA’s guidance on M4Q: The CTD — Quality and 102other related CTD guidance documents for detailed formatting recommendations on103preparing an application in CTD format.104105Module 3 of each NDA and ANDA should include the specified CTD sections: Drug 106Substance (3.2.S), Drug Product (3.2.P), Appendices (3.2.A), Regional Information107(3.2.R), and Literature References (3.3). In some cases, the majority of information to 108address the drug substance sections will be incorporated by reference from a master file 109(see section II.D.2). However, an applicant should still provide information to address 110some of the drug substance subsections. Recommendations on the content of the drug 111product section (3.2.P) of Module 3 will be the provided in the guidance Drug Product —112Chemistry, Manufacturing, and Controls Information (Drug Product guidance), when 113finalized.6 The Appendices, Regional Information, and Literature References sections 114include information for both drug substance and drug product, as appropriate.1155 The information in animal drug applications is commonly presented in the order of the required CMC informationspecified under section § 514.1(b)(4) and (5). Although the CTD-Q format was developed for human drugs, thedrug substance information to support NADAs and ANADAs can be formatted according to the CTD-Q format or any alternative format that provides the appropriate information to support the application.6 A draft version of this guidance published on January 28, 2003 (68 FR 4219).116This Drug Substance guidance has been organized in a format conforming to Module 3 of 117the CTD, and it provides CMC content recommendations specific to drug substance,118including recommendations for the Appendices, Regional Information, and Literature 119References sections. Alphanumeric designations in parentheses corresponding to the 120CTD format follow relevant headings and text to show where information is to be placed 121in the CTD.7 Recommendations specific to drug product, including recommendations for 122the Appendices, Regional Information and Literature References sections, will be123provided in the Drug Product guidance.124125Multiple Drug Substances in an Application126127When an application is submitted for a drug product involving two or more drug128substances (e.g., combination drug product, copackaged drug products), information for 129each drug substance should be presented separately in the application. Information130presented separately means one complete S section for one drug substance followed by 131other complete S sections for additional drug substances. All of the information pertinent 132to each one of the drug substances (general information, manufacture, characterization, 133control, standards, container closure system, and stability) should be provided in a single 134section.135136B. Content of an Application137The application should include information in every S subsection for each of the drug 138139substances and manufacturing schemes (e.g., alternative processes, manufacturing site) 140intended for approval under the application. Information should be provided in theAppendices, Regional Information, and Literature References sections for each of the 141142drug substances and manufacturing schemes, as appropriate. If an Appendices or143Regional Information subsection or the Literature References section is not applicable, 144this should be stated in the application.145146C. Additional Guidance147148This Drug Substance guidance and the Drug Product guidance, when finalized, will be 149the primary content guidances for NDA and ANDA applicants. For quality, the general 150format guidance is M4Q: The CTD — Quality. These are the first guidances an applicant 151should consider when preparing the quality section (i.e., chemistry, manufacturing, and 152controls) of an NDA or ANDA (Module 3).153This guidance references ICH guidance documents cited in the CTD-Q and FDA’s154155guidances on general technical topics (i.e., stability, container closure systems, analytical 156procedures and methods validation, sterilization process validation, drug master files, and7 Arabic numbers have been assigned to specific sections of the CTD. For example, the designation 3.2 before S, P,A, and R indicates Module 3, Body of Data section 2. Where this guidance discusses Module 3, Body of Datasection 2, for brevity, the initial designation 3.2 is not repeated throughout the rest of the guidance (e.g., 3.2.S.1.3reads S.1.3).157environmental assessments) rather than incorporating this detailed information. These 158guidances are referenced in the text and/or listed at the end of a section. An applicant159should refer to these guidances for recommendations on the detailed information that160should be included in the application to address the general technical topic.161162Finally, an applicant should consider guidances that are available for specific technical 163issues or type (e.g., synthetic peptides) of drug substance when preparing its application. 164These guidances provide additional recommendations on unique scientific and technical 165aspects of the topic. Some references to these types of guidances are included in this166guidance. However, the references are given only as examples, and the list is not meant 167to be all-inclusive. Some examples of these types of guidance include the following:168∙Submission of Chemistry, Manufacturing, and Controls Information for Synthetic 169170Peptide Substances171∙Submission of Chemistry, Manufacturing and Controls Information for a172Therapeutic Recombinant DNA-Derived Product or a Monoclonal Antibody173Product for In Vivo Use, CBER/CDER (under development)174∙Botanical Drug Products (under development)∙Fermentation Derived Drug Substances and Intermediates and Associated Drug 175176Products (under development)177∙Synthetic Oligonucleotides; Submission of Chemistry, Manufacturing, and178Controls Information (under development)179∙Radiopharmaceutical Drug Products: Chemistry, Manufacturing and ControlsInformation (under development)180181182FDA continues to update existing and publish new guidance documents. An applicant 183should use current guidance when preparing an NDA, ANDA, NADA or ANADA184submission.8185186D. References to Other Applications or Master Files (MFs)1871881. Other Applications189190In some cases, chemistry, manufacturing, and controls information about drug substances 191is provided in one application by reference to pertinent information in another application. 192This situation is less common than inclusion of information by reference to a MF and193usually occurs when the same firm submits both applications.194An applicant must identify in the application all other referenced applications, and each 195reference to information submitted in another application must identify where the196information can be found in the referenced application (21 CFR 314.50(a)(1) and197514.1(a)). If the referenced application was submitted by a firm other than the applicant,the referencing application must contain a written statement that authorizes the reference, 1988Current guidance documents are available on the Internet at /cder/guidance/index.htm,/cber/guidelines.htm, and /cvm/guidance/published.htm.199signed by the holder of the referenced application (21 CFR 314.50(g)(1), 314.420(b). and 200514.1(a)).9 Copies of letters of authorization (LOAs) should be submitted in Module 1 of 201the NDA or ANDA or in the appropriate section of an NADA or ANADA.2022032. Master Files (MFs)204205This guidance describes chemistry, manufacturing, and controls information for drug206substances that should be submitted to the Agency as part of the process of seeking theapproval of an NDA, ANDA, NADA, or ANADA. When a drug substance is207208manufactured by a firm other than the applicant, much of this information is frequently 209provided by reference to one or more Type II MFs rather than directly in an application. 210The CMC information in a Type II MF can be organized in CTD-Q format. Under FDA's 211regulations, an application can incorporate by reference all or part of the contents of any 212MF to address particular drug substance issues if the MF holder provides written213authorization (i.e., LOA) to the applicant and the authorization is included in the214application (Module 1 for an NDA or ANDA or in the appropriate section of an NADAor ANADA). The authorization must specifically identify the material being215216incorporated by reference (21 CFR 314.420 and 514.1(a)). The incorporated material217should be identified by name, reference number, volume and page number of the MF, anddate of submission. See 21 CFR 314.420, CDER’s guidance on Drug Master Files, and 218219CVM’s guidance on Preparation and Submission of Veterinary Master Files for moreinformation.220221222Both the applicant and the drug substance manufacturer (MF holder) contribute to223establishing and maintaining the identity, strength, quality, purity, and potency of the224applicant's drug products by manufacturing and controlling the drug substance in225accordance with the information submitted in the application and, by reference, in the MF. 226The following recommendations pertain to location of information in the MF and/or227application when an applicant and Type II MF holder are different firms.228229∙General Information (S.110): Both the MF and the application should include this 230information. These sections should contain similar, though not necessarily identical, 231information. For example, if an applicant performed screening studies and232established the existence of multiple polymorphs, information concerning these233polymorphs might be present in the application but not in the MF.234235∙Manufacture (S.2): The application should identify in S.2.1 the manufacturers of 236each drug substance with appropriate administrative information (see section IV.A). 237The MF should include this information for its manufacturing operations and any9 CVM discourages the reference of NDAs or ANDAs for drug substance information. In these instances, CVMrecommends that the drug substance information be included in a master file or incorporated in the applicant’sNADA or ANADA.10 Alphanumeric designations in parentheses that follow headings show where information should be placed inapplications that are submitted in Common Technical Document (CTD) format.238contract facilities that are used (e.g., intermediate manufacturers, laboratories). In239general, a MF can be referenced for the information recommended in S.2.2 through240S.2.6. However, the information should be augmented by the applicant, as241appropriate. For example, if the applicant micronizes drug substance purchased from242a MF holder the information on the micronization process should be included in the243application.244245∙Characterization (S.3): In general, a MF can be referenced for this information.However, the information should be augmented by the applicant, as appropriate. For 246247example, characterization information on physical properties critical to the applicant’s248product, such as solid state form or particle size distribution, should be included in249S.3.1 by the applicant under certain circumstances (e.g., applicant manipulates the250physical property (micronizes), the MF holder has not characterized the physical251property). Furthermore, information on an applicant’s studies to characterizeimpurities (S.3.2) can be warranted to support the applicant’s drug substance controls. 252253254∙Control of Drug Substance (S.4): In general, information recommended in S.4 should be provided in both the MF and the application. However, reference to an MF 255256can be appropriate for some of the information in S.4.2 through S.4.5 if the MF257holder and applicant are working together to develop the drug substance controls.Both the MF and the application should include a drug substance specification (S.4.1). 258259The MF could include more than one drug substance specification if the holder sellsdifferent technical grades of the drug substance (e.g., micronized and nonmicronized). 260261262∙Reference Standards (S.5): In general, information should be provided in both the 263MF and the application. However, reference to a MF can be appropriate for some of264the information if the MF holder and applicant are working together to develop the265reference standard.266267∙Container Closure System (S.6): In general, MFs can be referenced for this268information. However, the information should be augmented by the applicant, as269appropriate.270271∙Stability (S.7): In general, MFs can be referenced for this information. However, the information should be augmented by the applicant, as appropriate. For example, 272273an applicant might perform stress studies to support the analytical procedures it used274to control the drug substance.275276∙Appendices (A): In general, MFs can be referenced for this information. However, 277the information should be augmented by the applicant, as appropriate.278279∙Regional Information (R): Comparability protocols can be included in both the MF 280and application (R.2.S). A methods validation package should be included in theapplication (R.3.S).281282∙Literature References (3.3): Both the MF and the application should include283284literature references as warranted.285Type II MFs for drug substance intermediates can also be submitted in the CTD-Q format. 286287However, not all sections of the CTD-Q format would apply (e.g., S.4). The CMC288information provided to support an intermediate should be appropriate for the particularsituation (e.g., process, complexity of the molecule).289290291III. GENERAL INFORMATION (S.1)292293294General information on the nomenclature, structure, and general properties of the drug substance, should be provided in S.1.295296297A. Nomenclature (S.1.1)298299All appropriate names or designations for the drug substance should be provided in S.1.1. 300Any codes, abbreviations, or nicknames used in the application to identify the drug301substance should also be listed, including the following, if they exist or have been302proposed. A name that has not yet been finalized should be identified as proposed in the 303list.304305∙United States Adopted Name (USAN)∙Compendial name11306307∙Chemical names (e.g., Chemical Abstracts Service (CAS), International Union of 308Pure and Applied Chemistry (IUPAC))∙Company names or laboratory codes309310∙Other nonproprietary names (e.g., International Nonproprietary Name (INN),311British Approved Name (BAN), Japanese Accepted Name (JAN))312∙Chemical Abstracts Service (CAS) Registry Number313314B. Structure (S.1.2)315316Information on the chemical structure of the drug substance should be provided in S.1.2. 317This information should include:318319∙one or more drawings to show the overall chemical structure of the drug substance, 320including stereochemistry321∙molecular formula322∙molecular weight323324For a naturally derived protein drug substance, the information should include:11 A compendial name is a name that appears in an official compendium as defined in the Federal Food, Drug, andCosmetic Act (e.g., United States Pharmacopeia (USP)) (§ 201(j) (21 U.S.C. 32(i)).325326∙the schematic amino acid sequence indicating glycosylation sites or other327posttranslational modifications∙ a general description of the molecule (e.g., shape, disulfide bonds, subunit328329composition)330∙number of amino acid residues331∙molecular weight332333C. General Properties (S.1.3)334A list should be provided of the general physicochemical properties of the drug substance. 335336Other relevant properties of the drug substance should also be listed. Relevant properties 337are those physical, chemical, biological and microbiological attributes relating to theidentity, strength, quality, purity, and/or potency of the drug substance and, as338339appropriate, drug product. The information should include, as appropriate:340341∙ A general description (e.g., appearance, color, physical state)342∙Melting or boiling points343∙Optical rotation344∙Solubility profile (aqueous and nonaqueous, as applicable)345∙Solution pH346∙Partition coefficients347∙Dissociation constants348∙Identification of the physical form (e.g., polymorph, solvate, or hydrate) that will 349be used in the manufacture of the drug product350∙Biological activities351352For a naturally derived protein drug substance, additional information should be included, 353such as:354355∙Isoelectric point356∙Extinction coefficient357∙Any unique spectral characteristics358359If the drug substance can exist in more than one physical form, the information included 360in S.1.3 should be for the form (or forms) of the drug substance that will be used in the 361manufacture of the drug product. Detailed information on the characterization (e.g., X-362ray powder diffraction data, thermal analysis curves) of these and other physical forms 363and conditions required to produce one form or another should be provided in S.3.1.364。
ICHQ7(中英文)
INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USEICH H ARMONISED T RIPARTITE G UIDELINEG OOD M ANUFACTURING P RACTICE G UIDE FOR A CTIVE P HARMACEUTICAL I NGREDIENTSQ7Current Step 4 versiondated 10 November 2000This Guideline has been developed by the appropriate ICH Expert Working Group and has been subject to consultation by the regulatory parties, in accordance with the ICH Process. At Step 4 of the Process the final draft is recommended for adoption to the regulatory bodies of the European Union, Japan and USA.中英文对照Q7Current Step 4 versionG OOD M ANUFACTURING P RACTICE G UIDE FOR A CTIVE P HARMACEUTICAL I NGREDIENTSICH Harmonised Tripartite GuidelineHaving reached Step 4 of the ICH Process at the ICH Steering Committee meeting on 10 November 2000, this guideline is recommendedfor adoption to the three regulatory parties to ICHTable of Contents 目录1. INTRODUCTION 1. 前言1.1 Objective 1.1 目的1.2 Regulatory Applicability 1.2 法规的适用性1.3 Scope 1.3 范围2. QUALITY MANAGEMENT 2.质量管理2.1 Principles 2.1 总则2.2 Responsibilities of the Quality Unit(s) 2.2 质量部门的责任2.3 Responsibility for Production Activities 2.3 生产的职责2.4 Internal Audits (Self Inspection) 2.4 内部审计（自检）2.5 Product Quality Review 2.5 产品质量回顾3. PERSONNEL 3. 人员3.1 Personnel Qualifications 3.1人员资格3.2 Personnel Hygiene 3.2 个人卫生3.3 Consultants 3.3 顾问4. BUILDINGS AND FACILITIES 4. 建筑和设施4.1 Design and Construction 4.1 设计和建造4.2 Utilities 4.2 公用设施4.3 Water 4.3 水4.4 Containment 4.4 特殊限制4.5 Lighting 4.5 照明4.6 Sewage and Refuse 4.6 污物和废弃物4.7 Sanitation and Maintenance 4.7 卫生和维护5. PROCESS EQUIPMENT 5. 工艺设备5.1 Design and Construction 5.1 设计和建造5.2 Equipment Maintenance and Cleaning 5.2 设备维护和清洁5.3 Calibration 5.3 校验5.4 Computerized Systems 5.4 计算机控制系统6. DOCUMENTATION AND RECORDS 6. 文件和记录6.1 Documentation System and Specifications 6.1 文件系统和质量标准6.2 Equipment cleaning and Use Record 6.2 设备的清洁和使用记录6.3 Records of Raw Materials,Intermediates, 6.3 原料、中间体、原料药的标签和包装材料的记录API Labeling and Packaging Materials6.4 Master Production Instructions 6.4 主生产指令（主生产和控制记录）(Master Production and Control Records)6.5 Batch Production Records 6.5 批生产记录（批生产和控制记录）(BatchProduction and Control Records)6.6 Laboratory Control Records 6.6 实验室控制记录6.7 Batch Production Record Review 6.7 批生产记录审核7. MATERIALS MANAGEMENT 7. 物料管理7.1 General Controls 7.1 一般要求7.2 Receipt and Quarantine 7.2 接收和待验7.3 Sampling and Testing of Incoming Production Materials 7.3 来料的取样与检测7.4 Storage 7.4 储存7.5 Re-evaluation 7.5 再评价8. PRODUCTION AND IN-PROCESS CONTROLS 8. 生产管理和生产过程控制8.1 Production Operations 8.1 生产管理8.2 Time Limits 8.2 时限8.3 In-process Sampling and Controls 8.3 生产过程中的取样和控制8.4 Blending Batches of Intermediates or APIs 8.4 中间体或原料药的混批8.5 Contamination Control 8.5 污染控制9. PACKAGING AND IDENTIFICATION 9. 原料药和中间体的包装和贴签LABELING OF APIs AND INTERMEDIATES9.1 General 9.1 通则9.2 Packaging Materials 9.2 包装材料9.3 Label Issuance and Control 9.3 标签发放与管理9.4 Packaging and Labeling Operations 9.4 包装和贴签管理10. STORAGE AND DISTRIBUTION 10.储存和分发10.1 Warehousing Procedures 10.1 入库程序10.2 Distribution Procedures 10.2 分发程序11. LABORATORY CONTROLS 11.实验室管理11.1 General Controls 11.1通则11.2 Testing of Intermediates and APIs 11.2 中间体和原料药的检测11.3 Validation of Analytical Procedures 11.3 分析方法的验证11.4 Certificates of Analysis 11.4 检验报告11.5 Stability Monitoring of APIs 11.5 原料药的稳定性考察11.6 Expiry and Retest Dating 11.6 有效期和复验期11.7 Reserve/Retention Samples 11.7 留样12. VALIDATION 12.验证12.1 Validation Policy 12.1 验证方针12.2 Validation Documentation 12.2 验证文件12.3 Qualification 12.3 确认12.4 Approaches to Process Validation 12.4 工艺验证的方法12.5 Process Validation Program 12.5 工艺验证的程序12.6 Periodic Review of Validated Systems 12.6 对已验证的系统的定期回顾12.7 Cleaning Validation 12.7 清洗验证12.8 Validation of Analytical Methods 12.8 分析方法的验证13. CHANGE CONTROL 13.变更控制14. REJECTION AND RE-USE OF MATERIALS 14.物料的拒收和再利用14.1 Rejection 14.1 拒收14.2 Reprocessing 14.2 返工14.3 Reworking 14.3 重新加工14.4 Recovery of Materials and Solvents 14.4 物料与溶剂的回收14.5 Returns 14.5 退货15. COMPLAINTS AND RECALLS 15.投诉与召回16. CONTRACT MANUFACTURERS 16.协议生产商（包括实验室）(INCLUDING LABORATORIES)17. AGENTS, BROKERS, TRADERS, DISTRIBUTORS, 17.代理商、经纪人、贸易商、经销商、重新包装者REPACKERS, AND RELABELLERS 和重新贴签者17.1 Applicability 17.1 适用性17.2 Traceability of Distributed APIs and Intermediates 17.2 已分发的原料药和中间体的可追溯性17.3 Quality Management 17.3 质量管理17.4 Repackaging, Relabeling, and Holding of APIs and Intermediates 17.4 原料药和中间体的重新包装、重新贴签和待检17.5 Stability 17.5 稳定性17.6 Transfer of Information 17.6 信息的传达17.7 Handling of Complaints and Recalls 17.7 投诉和召回的处理17.8 Handling of Returns 17.8 退货的处理18. Specific Guidance for APIs Manufactured by Cell 18. 用细胞繁殖/发酵生产的原料药的特殊指南Culture/Fermentation18.1 General 18.1 总则18.2 Cell Bank Maintenance and Record Keeping 18.2 细胞库的维护和记录的保存18.3 Cell Culture/Fermentation 18.3 细胞繁殖/发酵18.4 Harvesting, Isolation and Purification 18.4 收取、分离和精制18.5 Viral Removal/Inactivation steps 18.5 病毒的去除/灭活步骤19. APIs for Use in Clinical Trials 19. 用于临床研究的原料药19.1 General 19.1 总则19.2 Quality 19.2 质量19.3 Equipment and Facilities 19.3 设备和设施19.4 Control of Raw Materials 19.4 原料的控制19.5 Production 19.5 生产19.6 Validation 19.6 验证19.7 Changes 19.7 变更19.8 Laboratory Controls 19.8 实验室控制19.9 Documentation 19.9 文件20. Glossary 20. 术语1. INTRODUCTION 1. 简介1.1 Objective 1.1 目的This document is intended to provide guidance regarding good manufacturing practice (GMP) for the manufacturing of active pharmaceutical ingredients (APIs) under an appropriate system for managing quality. It is also intended to help ensure that APIs meet the quality and purity characteristics that they purport, or are represented, to possess.本文件旨在提供在适当的体系下为了控制生产原料药的质量而实施的药品生产质量管理规范（GMP）的指南。
ITTC试验规程75-02-06-01
Table of Contents1. PURPOSE OF PROCEDURE .............. 22.DESCRIPTION OF PROCEDURE .... 2 2.1 Preparation . (2)2.1.1 Ship model characteristics ............ 2 2.1.2 Tank dimensions and water depth 3 2.1.3 Scale effects .................................. 3 2.1.4 Model inspection .......................... 4 2.1.5 Model equipment and set-up ........ 4 2.1.6 Wireless controlled models .......... 5 2.1.7 Wire controlled models ................ 5 2.1.8 Restricted water model ................. 5 2.2 Execution of Procedure ..................... 5 2.2.1 General considerations ................. 5 2.2.2 Initial test condition ...................... 5 2.2.3 Execution of tests ......................... 6 2.2.4 Test types in shallow and restrictedwater (7)2.2.5 Capture of model .......................... 7 2.3 Data Acquisition and Analysis ......... 7 2.3.1 Measured data ............................... 7 2.3.2 Specifics for shallow and restrictedwater (8)2.3.3 Data acquisition ............................ 8 2.3.4 Visual inspection .......................... 8 2.3.5 Analysis methods ......................... 8 2.4 Documentation .. (8)2.4.1 Ship model.................................... 8 2.4.2 Basin ............................................. 9 2.4.3 Restricted water model ................. 9 2.4.4 Ship model set-up ......................... 9 2.4.5 Measurement ................................ 9 2.4.6 Test parameters ............................ 9 2.4.7 Recording ..................................... 9 2.4.8 Calibration .................................... 9 2.4.9 Analysis procedure. . (9)3.PARAMETERS ..................................... 9 3.1 General ............................................... 9 3.2 Ship Control Parameters ................ 10 3.2.1 Propeller rates of revolutions ..... 10 3.2.2 Steering devices .......................... 10 3.2.3 Thrusters (lateral and azimuthingthrusters) ..................................... 10 3.3 Test Dependent Parameters ........... 10 3.3.1 Turning circle tests ..................... 10 3.3.2 Zig-zag or modified zig-zag tests.103.3.3 Spiral and reverse spiral tests. (10)4. UNCERTAINTY ................................. 105. BENCHMARK TESTS ....................... 106.REFERENCES (11)Free Running Model Tests1.PURPOSE OF PROCEDUREFree running model test techniques are ap-plied to predict manoeuvring characteristics of a full scale ship in a direct way. The results can also be used to develop a computer simulation model for further studies.Standard procedures for these types of tests are presented, together with recommended quantitative guidelines in order to ensure the quality and reliability of test results. The proce-dure is to be used for surface ships only, where Froude scaling law is applied.These guidelines are mainly based on the re-sults of a questionnaire distributed among ITTC member organisations in 2000 and 2001 (23rd ITTC Manoeuvring Committee Report, 2002).2.DESCRIPTION OF PROCEDURE 2.1Preparation2.1.1Ship model characteristicsThe following considerations should be made for selecting the scale and, therefore, the model dimensions.ScalePrincipally, the scale should be chosen as large as possible, meaning the model size should be as large as possible, keeping in mind that scale effects in manoeuvring are not yet fully understood, and the larger the model the smaller the scale effect.Also the size of the actual test basin in rela-tion to the required area for the tests to be carried out, as well as the capability of the test equip-ment are governing factors.Generally stock propellers are used and the scale is chosen with respect to a suitable propel-ler design. First the diameter should be scaled correctly and then the propeller pitch and blade area ratio should be as close to the real propeller as possible. According to an old rule of thumb the sum of the diameter and pitch (P+D) should be as close to full scale as possible if the correct diameter is not available. The number of blades should be considered as third priority.Ship modelThe ship model must have sufficient mate-rial strength and geometric accuracy. The geom-etry of the ship model, including rudder and pro-peller, is to be checked by inspection of its man-ufacturing accuracy, and by inspecting it for any obvious damage. All appendages should be modelled according to their originally designed shape.The turbulence stimulation device used, if any (wire, sand strips, or studs), should be de-scribed.The loading condition of the model (draft fore/aft and GM) should be checked before ex-periments and verified before and after the tests. The GM should be within 5% accuracy and theroll period (if known) as near as possible to the desired corresponding full scale values. When contradictory, a correct GM should prevail. I xx is usually tuned through roll decay tests at zero speed in which the roll period is adjusted. The yaw radius of gyration i zz is usually tuned to a typical value around 0.25 L PP.Since manoeuvring tests require similarity in the dynamic behaviour between the model and the full scale ship, the moments of inertia of the model should be scaled from full scale.2.1.2Tank dimensions and water depthThe size of the ship model should be selected such that the tank width is sufficient to prevent tank wall interference in the free running model test. On the other hand, for finite width cases the size of the ship model should be selected con-sidering the size of the restricted water model.Tests in deep water should be performed with a depth to draft ratio that is large enough to be free from shallow water effects. Referring to IMO (MSC/Cir 644), a minimum value of h/T = 4 is considered as acceptable. This figure, which accounts for practical issues of full scale trials, must be considered as a strict minimum for deep water model tests. The critical speed is defined as (gh)1/2. In deep water the test speed should be below 50% of the critical speed.For shallow water tests (h/T < 4) the depth should be scaled correctly; this may impose a re-striction on the maximum draft. At very small h/T, the vertical variations of the tank bottom should be less than 10% of the under keel clear-ance, which may determine the minimum draft. Some towing tanks use a false bottom to execute shallow water tests. In this case attention should be paid to a sufficient stiffness of the false bot-tom. Also water recirculation around the bound-aries of the false bottom can jeopardize the measurements.Shallow water implies a finite water depth. Lateral restrictions are also possible, which are referred to as restricted water (e.g. banks, other ships, harbour layout). Restricted water mostly implies shallow water, but not always (e.g. ship lightering or replenishment at sea).In shallow and restricted water the blockage (the ratio cross section of the ship to the cross section of the navigation area) has an influence on the critical speed.2.1.3Scale effectsIn manoeuvring tests with free running mod-els, the propeller(s) is used to give the model the desired speed, i.e. to produce the thrust to keep the desired speed, and also to produce a propel-ler induced flow over the rudder(s). Froude scal-ing of speed is generally applied and a tripping turbulence simulation device (wire, sand strips, or studs) should be fitted, as it probably will give a more realistic boundary layer development and pressure distribution along the hull.Two scale effect phenomena occur: the larger model wake fraction and the larger model resistance. If the propeller is operated at the model self propulsion point, the propeller load-ing condition may be excessive, hence the rud-der effectiveness of a model may generally be larger compared with that of a real ship. Accord-ingly, free running models tend to be more sta-ble (or less unstable) with respect to course keeping ability. This effect is typically less sig-nificant for fine ships because of their inherent stable course keeping ability. It is possible that the scale effects on the rudder can be neglected for some cases since the two scale effects may negate each other. This will be dependent onship type and can be evaluated based on ship-model correlation data.Sometimes it might be necessary to compen-sate the larger frictional resistance of the model with an additional propulsion device, e.g. a wind fan or air jet device. Guidelines for this still need to be established and there is no worldwide con-sensus.Since the rudder(s) are normally positioned in the wake field behind the ship and in the pro-peller race, i.e. in a very disturbed and turbulent flow, the Reynolds number effect for the rudder force may be neglected. Nevertheless sand strips or studs are sometimes applied to the rudder.Besides the above mentioned scale effects, there are unknown scale effects. These affect the side force and turning moment that a hull devel-ops while drifting and turning. There is no worldwide consensus on the magnitude or influ-ence of these scale effects yet.2.1.4Model inspectionThe model should be inspected, prior to launching and testing, for:∙principal dimensions,∙hull configuration,∙model mass,∙longitudinal and vertical centre of grav-ity positions,∙moments of inertia (about vertical z-axis;also about longitudinal x-axis if roll isimportant and/or about lateral y-axis iftrim or pitch are important),∙appendage alignment.2.1.5Model equipment and set-upThe model should be free to move in all 6 degrees of freedom and equipped with adequate propulsion and steering arrangement. The direc-tion of rotation of the propeller should be ac-cording to the full scale ship. Generally the pro-peller is run at a constant rpm throughout the complete test, except for the stopping test. How-ever, the real engine characteristics may be sim-ulated by controlling rpm with computing dy-namic response of the engine including torque limit. In order to model the engine, an instanta-neous measurement of the propeller torque is necessary. For a sufficient accurate measure-ment of torque, the propeller diameter should be larger than 10 cm. The instantaneous measured torque should be fed into the model control sys-tem, which may reduce the RPM of the vessel to achieve a constant torque, power or otherwise. The procedure of instantaneous modification of the propeller RPM is especially recommended for podded vessels.Free running models can either be designed to run autonomously with wireless remote con-trol or be positioned under a carriage, which fol-lows the model during the manoeuvre. Thus mo-tor power, control and measuring signals can easily be transferred between model and car-riage. In the latter case, the power, data, and con-trol cables should be arranged so that they do not affect the manoeuvre of the vessel.The range of measuring equipment should be chosen to be appropriate to the expected val-ues of the measurements. Calibration of sensors and driving units should be carried out immedi-ately before and immediately after testing.2.1.6Wireless controlled modelsThe testing system onboard a wireless con-trolled free running model may generally consist of the following devices.(1)Driving and manoeuvring control units(propulsion and rudder operation)(2)Computer which controls driving unitsand records measured results (when re-quired)(3)Sensors for yaw angle, yaw rate, rudderangle and propeller rpm (and for roll an-gle if applicable)(4)Telemeter with which control signals aretransmitted from the shore(5)Batteries and/or fuel for power supplyIn addition the position of the model has to be measured by an appropriate system. In open-air facilities, DGNSS or KGPS can be used. In enclosed facilities, optical or acoustic tracking systems are used. The important point of these measurements is the synchronizing between on board data and position data.2.1.7Wire controlled modelsThe testing system on board a wire con-trolled free running model may generally consist of the following devices:(1)Driving and manoeuvring control units(propulsion and rudder operation)(2)Sensors for yaw angle, yaw rate, rudderangle and propeller rpm (and for rollangle if applicable)In this case the data acquisition and driving unit controllers are installed on the carriage. The position of the model can then be measured through optical or mechanical means from the carriage; the absolute position of the model is then obtained by including the carriage position. 2.1.8Restricted water modelFor cases where finite water depth and/or fi-nite width are to be modelled using an artificial bottom and/or wall(s) the depth and width should be scaled correctly and the smoothness, stiffness and water pressure tightness of the re-stricted water model should be sufficient to not affect the results.2.2Execution of Procedure2.2.1General considerationsDistinction can be made between three phases of a free running manoeuvring test. The first is to establish the initial conditions for the actual test, the second is the test itself and the last the capture of the model when the test is fin-ished.The waiting time between tests should be sufficient to ensure that the next test is not dis-turbed by residual waves, current or remaining vortices in the water. It should be noted that the waiting time may be increased for restricted wa-ter cases. The wind at outdoor testing facilities should be negligible.The water temperature should be measured at some selected points at a depth of T/2.2.2.2Initial test conditionThe initial test condition is important. The limits of allowable deviation from the target in-itial test condition can be assessed following ITTC procedure 7.5-02-06-05 (Uncertainty analysis on free running model test).Most manoeuvring tests start from a straight course condition with as steady as possible val-ues of heading, speed, rpm and rudder angle orcorresponding (pod angle, water-jet steering nozzle angle, etc.). Straight-line speed runs should be carried out in order to find the propel-ler rpm corresponding to the desired test speed.Different methods are used to accelerate the model to the test speed:∙by model’s own propulsion system, maybe most common but requires rela-tively long distance,∙by catapult system,∙by a carriage which follows the model af-ter release.The initial value of the rudder angle may not be zero, but may be the value needed to sail straight ahead (neutral angle). During the straight-line speed runs, the initial neutral rud-der angle is determined. This rudder angle is never exactly zero. For single screw vessels, this can be explained by the asymmetry of the pro-peller force. For a twin screw ship, this may be a consequence of the asymmetry in model build, fitting of appendages or a slight asymmetry in propeller forces.The desired rudder angle for manoeuvres should be taken relative to amidships and not taken relative to the neutral angle.2.2.3Execution of testsThe test is initiated by the order to the steer-ing system to execute the actual test. The most common tests are those referred to in IMO Res-olution MSC.137(76):∙The turning (circle) test, generally started with a hard over rudder angle (generally35° starboard and port) and finished by apull-out by putting the rudder back to neu-tral angle after completing the turning testi.e. after reaching a steady yaw rate.∙The zig-zag test (10°/10︒, 20°/20︒, or modified), ideally the first two overshootsshould be accomplished when possible.These tests are conducted to port and star-board.∙The full astern stopping test is seldom car-ried out due to the scale effect (viscous re-sistance part) having a significant impacton the result.∙The spiral test, recommended by IMO in case of suspected course instability (couldbe determined from the residuary yaw rateat a pull-out test). The direct spiral testshould be carried out as turning tests at anumber of rudder angles and the steadyrate of turn measured. The tested rudderangles are usually 25︒, 20︒, 15︒, 10︒ and5︒ to starboard and port side. Smaller rud-der angles may be required for less stableand unstable ships.∙The reverse spiral test is performed to ac-quire the complete hysteresis loop whenthe ship is found unstable. It can also re-place the direct spiral test particularly ifthe test area does not allow a steady rateof turn to be established. For the reversespiral test autopilot is used to steer at aconstant yaw rate stepwise similar to theabove direct spiral test. In order to assurethat the complete spiral curve is obtained,the rudder should be steered in order to getsufficiently small constant yaw rate.Other common tests are:∙The pull-out test by going back to the steady course rudder angle after a shortexecute of the rudder (some 10︒) to portand starboard.∙The accelerating turning test starting from zero or a low speed and using full propul-sive power. Maximum rudder angle toport and starboard should be applied.For appropriate purposes free model tests can be performed to assess the performance of the ship in different conditions:∙bow thruster tests,∙crabbing tests,∙manoeuvring in restricted waters,∙manoeuvring in wind and/or waves.2.2.4Test types in shallow and restricted wa-terTypes of tests typically carried out in shal-low water are for the most part the same tests as in deep water: turning circle and zigzag tests are being carried out regularly. Additionally, in shallow water the “avoidance test” or “evasive test” for inland ships is being used. These spe-cific manoeuvres for inland ships are valid for ships sailing on the River Rhine in shallow wa-ter (ITTC 2014).The evasive manoeuvre is to be carried out as follows: At a constant speed of 13 km/hr and the ship well on its straight course, the steering angle is laid to the desired angle of 20 or 45 de-grees. That is at time t0. As soon as the rate of turn has achieved a limiting value in degrees per minute, the rudder is laid to the opposite side. This is time t1. When the rate of turn has become 0 degrees per minute, the time t2is clocked. When the rate of turn has achieved the target value again, the time t3 is noted, and the rudder is again reversed to the other side. When the rate of turn has become 0 again, the time t4 is noted, and the manoeuvre can end by steering back to the original heading. A criterion is used for the value of t4 depending on type of convoy and wa-ter depth.The specific manoeuvres for restricted water are usually so that the ships are sailing either in the neighbourhood of a bank or in the neigh-bourhood of other ships. In that case, the model(s) are steered by an autopilot (which is programmed in the ship control parameters) to keep a heading and/or a track.2.2.5Capture of modelAfter the test run is finished the model should be captured before preparing for the next test run. This is a more practical problem and can be solved in different ways and will not be treated here.2.3Data Acquisition and Analysis2.3.1Measured dataPerforming free running manoeuvring tests requires direct or indirect measurement of the following data:∙time,∙model position,∙heading,∙model speed, (axial and lateral or along track),∙yaw rate,and in some cases:∙roll angle,∙sinkage and trim.The measurement of parameters characteris-ing the control of ship model steering and pro-pulsion equipment should be recorded:∙rudder angle,∙rpm of propulsor(s),∙action of other steering/manoeuvring de-vices.The following data may also be important: ∙thrust/torque on propulsor(s),∙forces and moments on steering devices (rudder(s), pods…).2.3.2Specifics for shallow and restricted wa-terSpecifically for shallow and restricted water, it is important to measure the quantities as men-tioned in the previous section, and in addition, it is important to measure the squat of the free sail-ing model. Squat is characterised by sinkage and by trim.2.3.3Data acquisitionData sampling rate and filtering details should be determined on the basis of the re-sponse of the model, together with considera-tions of the primary noise frequencies. Sampling rates may vary between 4 and 250 Hz, 20 Hz be-ing a mean value. Sampling rate should be at least twice the filter frequency according to the sampling theory.2.3.4Visual inspectionThe measured real time data should be rec-orded. After each run the data should be in-spected in the time domain to check for obvious errors such as transients caused by recording too soon after starting, additional unknown sources of noise, overloading or failure of one or more sensors. The records of the driving units should be checked to verify that the correct orders were applied. 2.3.5Analysis methodsDetailed analysis is to be carried out with the use of stored data after the tests have been fin-ished, noting that data in transient regions of starting and stopping should not be used in the analysis. For the following standard manoeuvres the analysis is as follows:1) Turning testIndices such as the advance, transfer, tactical diameter, which represent turning characteris-tics of a ship, should be analyzed on the basis of the turning trajectory measured. Change in ad-vance speed and drift angle may also be ana-lysed on the basis of the turning trajectory.2) Zig-zag testOvershoot angles (usually for the 1st and 2nd oscillations), which represent course keeping ability and yaw checking ability of a ship, should be analyzed with the use of the time se-ries of yaw angle change in the zigzag test.3) Spiral and reverse spiral test4) Stopping testThe stopping distance can be obtained from the trajectory of the test.2.4DocumentationAt least the following information should be documented. The most relevant data should be included in the test report.2.4.1Ship model∙dimensions of hull, rudder, propeller, etc, ∙mass of model,∙position of centre of gravity,∙achieved GM value,∙achieved roll period value,∙moments of inertia,∙turbulence stimulation method,∙details of appendages,∙body plan and contours,∙engine/rpm control.2.4.2Basin∙dimensions,∙water depth,∙smoothness and stiffness of the bottom (for shallow water tests),∙average water temperature.2.4.3Restricted water model∙configuration,∙dimensions,∙smoothness and stiffness of the restricted water model (walls and/or bottom).2.4.4Ship model set-up∙powering,∙transfer of control signals,∙transfer of measuring signals.2.4.5Measurement∙measuring equipment,∙capacity of load cells,∙filter characteristics.2.4.6Test parameters∙test type,∙model speed,∙rudder angle or equivalent, ∙propeller rpm,∙water depth to draft ratio,∙location of ship in relation to restricted water model.2.4.7Recording∙equipment,∙sample time,∙digitising rate.2.4.8Calibration∙details of all calibrations conducted,∙information on linearity and repeatability of all sensors.2.4.9Analysis procedure.∙method of analysis,∙filtering technique.3.PARAMETERS3.1GeneralThe following parameters should be taken into account for all free running manoeuvring model tests:∙scale,∙model dimensions,∙ratios of model to basin dimensions,∙water depth,∙hull configuration,∙propulsion and steering arrangements,∙loading condition of ship model,∙model mass,∙position of centre of gravity of ship model, ∙moments of inertia of ship model.3.2Ship Control Parameters3.2.1Propeller rates of revolutionsMost tests should be carried out either at the model self-propulsion point or at the full scale self-propulsion point. The latter method requires a towing force to be applied, which corresponds to the difference in viscous drag (friction deduc-tion). However, this correction will depend on the model scale and the ship type and it is not generally done (See Section 2.1.1.4).3.2.2Steering devicesThe rudder turning rate should be scaled ac-cording to Froude’s model law. The maximum angle should be determined according to the purpose of the tests, and in most cases coincides with 'hard over', although a lower deflection could be sufficient for some purposes.3.2.3Thrusters (lateral and azimuthing thrust-ers)The thrust or power developed by the in-stalled thruster unit at zero speed is regulated to match the design ship value. If the thrust is not measured, it is important that power and diame-ter are correct.3.3Test Dependent Parameters3.3.1Turning circle testsThe following parameters should especially be taken into account in addition to those in Sec-tion 2.3.4:∙initial forward speed(s) u,∙initial propeller rate(s) of rotations n,∙ordered and actual steering device angle δ.3.3.2Zig-zag or modified zig-zag tests.The following parameters should especially be taken into account in addition to those in Sec-tion 2.3.4:∙initial forward speed(s) u,∙initial propeller rate(s) of rotations n,∙ordered and actual steering device angle δand heading angle ψ (δ/ψ i.e. 10°/10° or20°/20°) ,∙turning speed of steering device.3.3.3Spiral and reverse spiral tests.Following parameters should especially be taken into account:∙initial forward speed(s) u,∙initial propeller rate(s) of rotations n,∙steering device angles δ or corresponding, ∙yaw rate r.4.UNCERTAINTYDuring free manoeuvring tests, a ship model is free to move in all 6 degrees of freedom. The manoeuvre is actuated by one or more steering devices, propulsors and thrusters.The accuracy of test results is influenced by imperfections of the experimental technique. This is addressed in a separate ITTC procedure 7.5-02-06-05 (Uncertainty analysis on free run-ning model tests).5.BENCHMARK TESTS1)Preliminary Analysis of ITTC Co-operativeTests Programme (11th 1966 pp.486-508) A Mariner Class Vessel2)The Co-operative Free-Model Manoeu-vring Program (13th 1972 pp.1000)3)Co-operative Test Program - Second Anal-ysis of Results of Free Model Manoeuvring Tests (13th 1972 pp.1074-1079) A MARI-NER Type Ship4)Ship Model Correlation in Manoeuvrability(17th 1984 pp.427-435) Joint International Manoeuvring Program (JIMP), a Working Group Called JAMP (Japan Manoeuvrabil-ity Prediction)5)Free-Running Model Tests with ESSOOSAKA, (18th 1987 pp.369-371)6)SIMMAN 2008 Benchmark cases forKVLCC1, KVLCC2, KCS and 5415M. 7)SIMMAN 2014, Benchmark cases forKVLCC2, KCS and 5415M6.REFERENCESInternational Maritime Organization, “Stand-ards for Ship Manoeuvrability”, Resolution MSC.137(76), 2002. International Towing Tank Conference, 1996, "Manoeuvring Committee - Final Report and Recommendations to the 21st ITTC", Proceedings of 21st ITTC, Bergen / Trond-heim, Norway, Vol. 1, pp. 347-398. International Towing Tank Conference, 1999, "Manoeuvring Committee - Final Report and Recommendations to the 22nd ITTC", Proceedings of 22nd ITTC, Seoul/Shanghai. International Towing Tank Conference, 2014, "Manoeuvring Committee - Final Report and Recommendations to the 27th ITTC", Proceedings of 27th ITTC, Copenhagen. Stern, F. and Agdrup, K.; Proceedings of SIM-MAN2008, workshop on ship manoeuvra-bility, Copenhagen, 2008.。
ITTC – Recommended Procedures and Guidelines
Loads and Responses, Seakeeping Experiments on Rarely OccurringEventsEffective Date 2002 Revision01Updated byApprovedLoad and Responses Committee of 23rd ITTC23rd ITTCDate 2002 DateTable of Contents1 PURPOSE OF PROCEDURE……...2 2STANDARDS FOR EXPERIMENTS ON RARELY OCCURRINGEVENTS……………………………….2 2.1 Previous Recommendations ofITTC.................................................2 2.2 Model Design and Construction....2 2.3Standard for Duration andRepetition of Test Runs (2)2.4 Video Recording..............................3 2.5Criteria (3)3 PARAMETERS………………………..34 VALIDATION…………………………3 4.1 Uncertainty Analysis.......................3 4.2Benchmark Tests (3)Loads and Responses, Sea Keeping Experiments on Rarely OccurringEvents Effective Date2002Revision01Experiments on Rarely Occurring Events1PURPOSE OF PROCEDUREThe rarely occurring events are associated with slamming, green water, large amplitude motion, acceleration, etc. of ships and offshore structures.Purpose of this procedure is to de-fine standards for experiments on rarely occur-ring events.2STANDARDS FOR EXPERIMENTS ON RARELY OCCURRING EVENTS2.1Previous Recommendations of ITTC1987 pp 525 When performing tests on moored systems special note should be taken of the lack of model/full scale correlation of the low frequency motions, the importance of the system damping, and the potentially important scale effects on damping that may influence the results of the tests.1996 pp 295 Recent studies carried out with multi or single point moored vessels have shown that most severe loads do not occur when wind, wave and current are co-linear and therefore it is necessary to consider the point probabilities of both the magnitude of the wind, wave and current parameters and their direc-tion. 2.2Model Design and ConstructionThe model scale should be as large as prac-ticable with respect to the test facility em-ployed and appropriate to enable the requisite of full scale significant wave height to be gen-erated.The model should be complete up to the upper-most weather deck, including forecastle, bulwarks, deck fittings, deckhouses and freeing ports. The model should be equipped with ex-ternal appendages such as bilge keels, rudder, or fins as may reasonably be expected to influ-ence the results of the tests.It is recommended that ship models should be self-propelled and remotely controlled, ei-ther by radio or by a light umbilical attach-ment; or towed from a carriage equipped with the capability for free-to-surge under constant towing force, with freedom to heave, pitch and roll.2.3Standard for Duration and Repetitionof Test RunsThe following interim recommended proce-dure for experiments on rarely occurring events is proposed:Experiments to determine the statistics of rarely occurring events such as slamming and deck wetness in irregular waves should last for a minimum of one hour for ship and threeLoads and Responses, Sea Keeping Experiments on Rarely OccurringEvents Effective Date2002Revision01hours for moored floating offshore structures (full scale equivalent). Care should be taken to avoid a repeating wave time history. Alterna-tively, selected time histories with rare wave events can be used instead. In comparative tests (e.g. to establish the relative merits of different designs) the wave conditions should be chosen so that a substantial number of events occur.2.4Video RecordingVideo recording of test and rarely occurring events is recommended.2.5CriteriaCriteria for acceptable motions and other rough weather phenomena are all too often not related to specific activities of the ship. The Committee recommends that ship model basins should play a more active role in determining criteria and that:a.Criteria should relate to responses thatare of specific importance to the mis-sion considered.b.Acceptable response levels should bedetermined by long term monitoring ofdata, trials, questionnaires or discus-sions with the operators.3PARAMETERSThe following parameters could be taken into account: •Relative water level at different hull posi-tions•Accelerations•Instrumentation to measure roll and pitch angles, and heave position may be deemed helpful•Frequency of deck wetness•Volume of water accumulated during each test run•Impact loads (pressure or forces, moments) due to green water or slamming•State dynamic properties of model, such as stiffness and natural periods•Waves4VALIDATION4.1Uncertainty AnalysisNone4.2Benchmark Tests1) Seagoing Quality of Ships(7th 1955 pp.247-293)A Model of the Todd-Forest Series 60,Cb=0.60:7 tanks used 5ft. models, 2 tanks used 10 ft.models, and 1 tank used 16 ft. model Froude Numbers 0,0.18,0.21,0.24,0.27 and0.30The Ratio wave height to the Length of the Model: 1/36 1/48 1/60 1/72 for Wave Length 0.75L 1.0L 1.25L 1.5L 2) Comparative Tests in Waves at Three Ex-perimental Establishments Using the Same Model(11th 1966 pp.332-342)Loads and Responses, Sea Keeping Experiments on Rarely OccurringEvents Effective Date2002Revision01British Towing Tank Panel: A 10 ft. Fibre-Glass Model of the S.S.CairndhuA Series of Experiments on a Ship Model inRegular Waves Using Different Test Tech-niquesData Obtained in Irregular and Transient Waves and Some Result Predicted by theTheory (Based on Korvin Kroukovsky's Work and Employing the Added Mass andDamping Coefficients Calculated by Grim) 3) Full Scale Destroyer Motion Measurements(11th l966 pp.342-350)Full Scale Destroyer Motion Tests in HeadSeaComparison among Motion Response Ob-tained from Full Scale Tests, Model Ex-periments and Computer CalculationsThe Destroyer H.M. "Groningen” of the Royal Netherlands NavyA Scale Ration 40 to 14) Comparison of the Computer Calculations ofShip Motions (11th 1966 pp.350-355)ShipResponseFunctionsfortheSeries60Cb=0.70 Parent Form5) Computer Program Results for Ship Behav-iour in Regular Oblique Waves(11th l966 pp.408~-411)Series 60, Cb=0.60 and 0.70 Parent FormDTMB Model 421OW and 4212W6) Experiments in Head Seas6-1) Comparative Tests of a Series 60 Ship Model in Regular Waves(11th 1966 pp.411-415)Series 60 Cb=0.60 6-2) Experiments on Heaving and Pitching Motions of a Ship Model in Regular Longi-tudinal Waves (11th 1966 pp.415-418)Series 60 Cb=0.606-3) Experiments on the Series 60, Cb=0.60 and 0.70 Ship Models in Regular Head Waves(11th 1966 pp.418-420)Series 60, ~Cb=0.60 and 0.706-4) Comparison of Measured Ship Motions and Thrust Increase of Series 60 Ship Mod-els in Regular Head Waves (11th 1966 pp.420-426)Series 60, ~Cb=0. 60 and 0. 706-5) Estimation of Ship Behaviour at Sea from Limited Observation (11th 1966 ~pp.426-428)7) Computer Results, Head Seas7-1) Theoretical Calculations of Ship Motions and Vertical Wave Bending Moments in Regular Head Seas (11th 1966 pp. 428-430) Series 60, Cb=0.707-2) Comparison of Computer Program Results and Experiments for Ship Behaviour in Regular Head Seas (11th l966 pp.430-432)Series 60, ~Cb=0.60 and 0.707-3) Computer Program Results for Ship Be-haviour in Regular Head Waves(11th 1966 pp.433-436) Series 60, Cb=0.60 and 0.70 Parent Form DTMB Model 421OW and 4212W7-4) Comparison of Calculated and Measured Heaving and Pitching Motions of a SeriesLoads and Responses, Sea Keeping Experiments on Rarely OccurringEvents Effective Date2002Revision0160, Cb=0.70 Ship Model in Regular Longi-tudinal Waves (11th 1966 pp.436-442)Series 60, Cb=0.707-5) Computer Calculations of Ship Motions (11th 1966 pp.442)7-6) Comparison of the Computer Calculations of Ship Motions and Vertical Wave Bending Moment ( 11th 1966 pp. 442-445)Series 60, Cb=0.60 and 0.708) Comparison of the Computer Calculationsfor Ship Motions and Seakeeping Qualities by Strip Theory (14th 1975 Vol.4pp.341-350)A Large-Sized Ore Carrier9) Comparison on Results Obtained with Com-puter Programs to Predict Ship Motions in Six Degrees of Freedom(15th 1978 pp. 79-90)S-175, Cb = 0. 57210) Comparison of Results Obtained withCompute Programs to Predict Ship Motions in Six-Degrees-of-Freedom and Associated Responses (16th 1981 pp.217-224)To Identify the Differences in the Various Strip Theories and Computation Procedures utilised by the Various Computer Programsand Provide Guidance for Improvement if NecessaryS-175 Container Ship for Fn = 0.27511) Analysis of the S-175 Comparative Study(17th 1984 pp.503-511)12) S-175 Comparative Model Experiments(18th 1987 pp.415-427)13) Rare Events(19th 1990 pp.434-442, Seakeeping)14) Validation Standards of Reporting and Un-certainty Analysis Strip Theory Predictions ( 19th 1990 pp.460-464)15) ITTC Database of Seakeeping Experiments(20th 1993 pp.449-451)Two Dimensional Model, Wigley Hull Form, S-17516) Validation of Seakeeping Calculations (21st1996 pp.41-43)Basic Theoretical LimitationsNumerical Software Engineering Aspects 17) ITTC Database of Seakeeping Experiments(21st 1996 pp.43)S-175, High Speed Marine Vehicle。
ITU-T-G.826
INTERNATIONAL TELECOMMUNICATION UNIONITU-T G.826(12/2002) TELECOMMUNICATIONSTANDARDIZATION SECTOROF ITUSERIES G: TRANSMISSION SYSTEMS AND MEDIA, DIGITAL SYSTEMS AND NETWORKSDigital networks – Quality and availability targetsEnd-to-end error performance parameters and objectives for international, constant bit-rate digital paths and connectionsITU-T Recommendation G.826ITU-T G-SERIES RECOMMENDATIONSTRANSMISSION SYSTEMS AND MEDIA, DIGITAL SYSTEMS AND NETWORKS INTERNATIONAL TELEPHONE CONNECTIONS AND CIRCUITS G.100–G.199G.200–G.299 GENERAL CHARACTERISTICS COMMON TO ALL ANALOGUE CARRIER-TRANSMISSION SYSTEMSG.300–G.399 INDIVIDUAL CHARACTERISTICS OF INTERNATIONAL CARRIER TELEPHONESYSTEMS ON METALLIC LINESG.400–G.449 GENERAL CHARACTERISTICS OF INTERNATIONAL CARRIER TELEPHONESYSTEMS ON RADIO-RELAY OR SATELLITE LINKS AND INTERCONNECTION WITHMETALLIC LINESCOORDINATION OF RADIOTELEPHONY AND LINE TELEPHONY G.450–G.499 TESTING EQUIPMENTS G.500–G.599 TRANSMISSION MEDIA CHARACTERISTICS G.600–G.699 DIGITAL TERMINAL EQUIPMENTS G.700–G.799 DIGITAL NETWORKS G.800–G.899 General aspects G.800–G.809 Design objectives for digital networks G.810–G.819 Quality and availability targets G.820–G.829 Network capabilities and functions G.830–G.839 SDH network characteristics G.840–G.849 Management of transport network G.850–G.859 SDH radio and satellite systems integration G.860–G.869 Optical transport networks G.870–G.879 DIGITAL SECTIONS AND DIGITAL LINE SYSTEM G.900–G.999 QUALITY OF SERVICE AND PERFORMANCE G.1000–G.1999 TRANSMISSION MEDIA CHARACTERISTICS G.6000–G.6999 DIGITAL TERMINAL EQUIPMENTS G.7000–G.7999 DIGITAL NETWORKS G.8000–G.8999For further details, please refer to the list of ITU-T Recommendations.ITU-T Recommendation G.826End-to-end error performance parameters and objectives for international,constant bit-rate digital paths and connectionsSummaryThis Recommendation defines end-to-end error performance parameters and objectives for international digital paths which operate at or above the primary rate and for international digital connections which operate below the primary rate of the digital hierarchy. The objectives given are independent of the physical network supporting the path or connection.For digital paths which operate at or above the primary rate, this Recommendation is based upon a block-based measurement concept using error detection codes inherent to the path under test. This supports in-service measurements.For digital connections which operate below the primary rate of the digital hierarchy, this Recommendation is based upon bit error and bit error ratio measurements. This approach does not support in-service measurements.Annex A deals with the definition of availability of the path or connection. Annexes B, C and D give specific information concerning PDH, SDH and cell-based transmission paths.It is not required to apply this Recommendation to connections which operate below the primary rate using equipment designed prior to the adoption of this Recommendation in December 2002.This Recommendation deals with the performance of PDH paths, and of those SDH paths using equipment designed prior to the adoption of ITU-T Rec. G.828 in March 2000. ITU-T Rec. G.828 deals with the performance of SDH paths using equipment designed as of or after the adoption of ITU-T Rec. G.828 in March 2000. New Recommendation G.8201 deals with performance of ODUk paths of the OTN.SourceITU-T Recommendation G.826 was revised by ITU-T Study Group 13 (2001-2004) and approved under the WTSA Resolution 1 procedure on 14 December 2002.KeywordsBackground block error, background block error ratio, bit error, bit error ratio, block-based concept, digital connection, digital path, error detection codes, error performance objectives, error performance parameters, errored second, in-service measurements, severely errored second.ITU-T Rec. G.826 (12/2002) iFOREWORDThe International Telecommunication Union (ITU) is the United Nations specialized agency in the field of telecommunications. The ITU Telecommunication Standardization Sector (ITU-T) is a permanent organ of ITU. ITU-T is responsible for studying technical, operating and tariff questions and issuing Recommendations on them with a view to standardizing telecommunications on a worldwide basis.The World Telecommunication Standardization Assembly (WTSA), which meets every four years, establishes the topics for study by the ITU-T study groups which, in turn, produce Recommendations on these topics.The approval of ITU-T Recommendations is covered by the procedure laid down in WTSA Resolution 1.In some areas of information technology which fall within ITU-T's purview, the necessary standards are prepared on a collaborative basis with ISO and IEC.NOTEIn this Recommendation, the expression "Administration" is used for conciseness to indicate both a telecommunication administration and a recognized operating agency.INTELLECTUAL PROPERTY RIGHTSITU draws attention to the possibility that the practice or implementation of this Recommendation may involve the use of a claimed Intellectual Property Right. ITU takes no position concerning the evidence, validity or applicability of claimed Intellectual Property Rights, whether asserted by ITU members or others outside of the Recommendation development process.As of the date of approval of this Recommendation, ITU had not received notice of intellectual property, protected by patents, which may be required to implement this Recommendation. However, implementors are cautioned that this may not represent the latest information and are therefore strongly urged to consult the TSB patent database.ITU 2003All rights reserved. No part of this publication may be reproduced, by any means whatsoever, without the prior written permission of ITU.ii ITU-T Rec. G.826 (12/2002)CONTENTSPage1 Scope (1)1.1 Application of this Recommendation (1)1.2 Transport network layers (2)1.2.1 PDH and SDH transport networks (2)connections (2)1.2.2 ATM1.3 Allocation of end-to-end performance (3)2 References (3)3 Abbreviations (4)4 Terms and definitions (6)4.5 Error performance events for paths (6)4.6 Error performance events for connections (7)4.7 Error performance parameters (7)5 The measurement of the block (7)5.1 In-service monitoring of blocks (7)5.2 Out-of-service measurements of blocks (8)assessment (8)6 Performance6.1 Implications for error performance measuring devices (8)6.2 Performance monitoring at the near end and far end of a path (8)7 Error performance objectives (8)objectives (8)7.1 End-to-end7.2 Apportionment of end-to-end objectives (10)7.2.1 Allocation to the national portion of the end-to-end path or connection (10)7.2.2 Allocation to the international portion of the end-to-end path orconnection (11)Annex A – Criteria for entry and exit for the unavailable state (11)A.1 Criteria for a single direction (11)A.2 Criterion for a bidirectional path or connection (12)A.3 Criterion for a unidirectional path or connection (12)A.4 Consequences on error performance measurements (12)Annex B – Relationship between PDH path performance monitoring and the block-based parameters (13)B.1 General (13)B.1.1 Block size for monitoring PDH paths (13)B.1.2 Anomalies (13)B.1.3 Defects (13)ITU-T Rec. G.826 (12/2002) iiiPageB.2 Types of paths (14)B.3 Estimation of the performance parameters (14)B.4 In-service monitoring capabilities and criteria for declaration of theperformance parameters (15)B.5 Estimation of performance events at the far end of a path (16)B.6 Differences between this Recommendation and ITU-T Rec. M.2100concerning path performance (16)B.6.1 General (16)B.6.2 Allocationmethodology (16)Annex C – Relationship between SDH path performance monitoring and the block-based parameters (17)C.1 General (17)C.1.1 Converting BIP measurements into errored blocks (17)C.1.2 Block size for monitoring SDH paths (17)C.1.3 Anomalies (17)C.1.4 Defects (17)C.1.5 Measurement of performance events using aggregate parity error counts (18)C.2 Estimation of the performance parameters (19)C.3 Estimation of performance events at the far end of a path (19)Annex D – Relationship between cell-based network performance monitoring and theblock-based parameters (19)D.1 General (19)D.1.1 Block size for monitoring cell-based paths (19)D.1.2 Anomalies (20)D.1.3 Defects (20)D.2 Types of paths (21)D.3 Estimation of the performance parameters (21)D.4 Estimation of performance events at the far end of the path (21)Appendix I – Flow chart illustrating for digital paths the recognition of anomalies,defects, errored blocks, ES and SES (22)Appendix II – Bit errors and block errors, merits and limitations (23)Appendix III – Applicability of this Recommendation to non-public networks (24)iv ITU-T Rec. G.826 (12/2002)ITU-T Recommendation G.826End-to-end error performance parameters and objectives for international,constant bit-rate digital paths and connections1 ScopeThis Recommendation specifies end-to-end error performance events, parameters and objectives for:1) digital paths operating at bit rates at or above the primary rate; and2) N × 64 kbit/s circuit-switched digital connection (1 ≤ N ≤ 24 or 31 respectively).This Recommendation also specifies allocations of the end-to-end performance objectives.1.1 Application of this RecommendationThis Recommendation is applicable to international, constant bit-rate digital paths which operate at or above the primary rate and to international N × 64 kbit/s (1 ≤ N ≤ 24 or 31 respectively) digital connections.NOTE – It is not required to apply this Recommendation to connections which operate below the primary rate using equipment designed prior to the adoption of this Recommendation in December 2002. Performance events and objectives for connections using equipment designed prior to this date are given in ITU-T Rec. G.821 [14].The constant bit-rate digital paths may be based on a Plesiochronous Digital Hierarchy, Synchronous Digital Hierarchy or some other transport network such as cell-based. This Recommendation is generic in that it defines the parameters and objectives for the paths and connections independent of the physical transport network. Compliance with the path performance specification of this Recommendation will, in most cases, also ensure that a client 64 kbit/s connection will meet its requirements. Therefore, this Recommendation and ITU-T Rec. G.828 [24] are currently the only Recommendations required for designing the error performance of digital paths at or above the primary rate1. In accordance with the definition of a digital path, path end points may be located at user's premises.Paths are used to support services such as circuit switched, packet switched and leased circuit services. The quality of such services, as well as the performance of the network elements belonging to the service layer, is outside of the scope of this Recommendation.The performance objectives are applicable to a single direction of the path or connection. The values apply end-to-end over a 27 500 km Hypothetical Reference Path or Connection (see Figure 3), which may include optical fibre, digital radio relay, metallic cable and satellite transmission systems. The performance of multiplex and cross-connect functions employing ATM techniques is not included in these values.The parameter definitions for digital paths which operate at or above the primary rate are block-based, making in-service measurement convenient. In some cases, the network fabric is not able to provide the basic events necessary to directly obtain the performance parameters. In these cases, compliance with this Recommendation can be assessed using out-of-service measurements or estimated by measures compatible with this Recommendation, such as those specified in ____________________1This Recommendation deals with the performance of PDH paths, and of those SDH paths using equipment designed prior to the adoption of ITU-T Rec. G.828 in March 2000. ITU-T Rec. G.828 deals with the performance of SDH paths using equipment designed as of or after the adoption of ITU-T Rec.G.828 in March 2000. New ITU-T Rec. G.8201 deals with the performance of ODUk paths of the OTN.ITU-T Rec. G.826 (12/2002) 12 ITU-T Rec. G.826 (12/2002)Annexes B, C and D. The parameter definitions for digital connections which operate below the primary rate of the digital hierarchy are not block-based; rather, they are based upon bit error and bit-error ratio measurements. 1.2Transport network layersFor paths, this Recommendation specifies the error performance in a given transport network layer. Two cases have to be considered: 1.2.1PDH and SDH transport networksFigure 1 gives the intended scope where ATM does not form part of the end-to-end path. It should be noted that end-to-end performance monitoring is only possible if the monitored blocks together with the accompanying overhead are transmitted transparently to the path end points.G.826_F01Application of this RecommendationNetwork fabric, e.g., PDH, SDH A BNOTE – A and B are path end points located at physical interfaces, e.g. in accordance with ITU-T Rec. G.703 [1].Figure 1/G.826 – Application of this Recommendationfor a non-ATM end-to-end transmission path1.2.2 ATM connectionsWhere the path forms the physical part of an ATM connection (see Figure 2), the overall end-to-end performance of the ATM connection is defined by ITU-T Rec. I.356 [16]. In this case, this Recommendation can be applied with an appropriate allocation to the performance between the path end points where the physical layer of the ATM protocol reference model (see ITU-T Rec. I.321 [15]) is terminated by ATM cross-connects or switches. ATM transmission paths in the physical layer correspond to a stream of cells mapped either into a cell-based format or into SDH or PDH-based frame structures.G.826_F02Under study ITU-T Rec. I.356AAL ATM PLATM PLPLAAL ATM PLG.826 allocatedG.826 allocatedAAL ATM Adaptation Layer ATM ATM Layer PL Physical LayerFigure 2/G.826 – Architectural relationship betweenthis Recommendation G.826 and ITU-T Rec. I.356 [16]1.3 Allocation of end-to-end performanceAllocations of end-to-end performance of CBR paths and connections are derived using the rules laid out in 7.2 which are length- and complexity-based. Detailed allocations of G.826 performance to the individual components (lines, sections, multiplexers and cross-connects, etc.) are outside the scope of this Recommendation, but when such allocations are performed, the national and international allocations as given in 7.2 shall be achieved.2 ReferencesThe following ITU-T Recommendations and other references contain provisions which, through reference in this text, constitute provisions of this Recommendation. At the time of publication, the editions indicated were valid. All Recommendations and other references are subject to revision; users of this Recommendation are therefore encouraged to investigate the possibility of applying the most recent edition of the Recommendations and other references listed below. A list of the currently valid ITU-T Recommendations is regularly published. The reference to a document within this Recommendation does not give it, as a stand-alone document, the status of a Recommendation [1] ITU-T Recommendation G.703 (2001), Physical/electrical characteristics of hierarchicaldigital interfaces.[2] ITU-T Recommendation G.704 (1998), Synchronous frame structures used at 1544, 6312,2048, 8448 and 44 736 kbit/s hierarchical levels.[3] ITU-T Recommendation G.707/Y.1322 (2000), Network node interface for thesynchronous digital hierarchy (SDH), plus Corrigendum 1 (2001), Corrigendum 2 (2001),and Amendment 1 (2001).[4] ITU-T Recommendation G.732 (1988), Characteristics of primary PCM multiplexequipment operating at 2048 kbit/s.[5] ITU-T Recommendation G.733 (1988), Characteristics of primary PCM multiplexequipment operating at 1544 kbit/s.[6] ITU-T Recommendation G.734 (1988), Characteristics of synchronous digital multiplexequipment operating at 1544 kbit/s.[7] ITU-T Recommendation G.742 (1988), Second order digital multiplex equipment operatingat 8448 kbit/s and using positive justification.[8] ITU-T Recommendation G.743 (1988), Second order digital multiplex equipment operatingat 6312 kbit/s and using positive justification.[9] ITU-T Recommendation G.751 (1988), Digital multiplex equipments operating at the thirdorder bit rate of 34 368 kbit/s and the fourth order bit rate of 139 264 kbit/s and usingpositive justification.[10] ITU-T Recommendation G.752 (1988), Characteristics of digital multiplex equipmentsbased on a second order bit rate of 6312 kbit/s and using positive justification.[11] ITU-T Recommendation G.755 (1988), Digital multiplex equipment operating at139 264 kbit/s and multiplexing three tributaries at 44 736 kbit/s.[12] ITU-T Recommendation G.775 (1998), Loss of Signal (LOS), Alarm Indication Signal(AIS) and Remote Defect Indication (RDI) defect detection and clearance criteria for PDHsignals.[13] ITU-T Recommendation G.783 (2000), Characteristics of synchronous digital hierarchy(SDH) equipment functional blocks, plus Corrigendum 1 (2001).ITU-T Rec. G.826 (12/2002) 3[14] ITU-T Recommendation G.821 (2002), Error performance of an international digitalconnection operating at a bit rate below the primary rate and forming part of an Integrated Services Digital Network.[15] ITU-T Recommendation I.321 (1991), B-ISDN protocol reference model and itsapplication.[16] ITU-T Recommendation I.356 (2000), B-ISDN ATM layer cell transfer performance.[17] ITU-T Recommendation I.3622, B-ISDN ATM adaptation layer (AAL) functionaldescription.[18] ITU-T Recommendations I.432.x series, B-ISDN user-network interface – Physical layerspecification.[19] ITU-T Recommendation I.610 (1999), B-ISDN operation and maintenance principles andfunctions, plus Corrigendum 1 (2000).[20] ITU-T Recommendation M.60 (1993), Maintenance terminology and definitions.[21] ITU-T Recommendation M.2100 (1995), Performance limits for bringing-into-service andmaintenance of international PDH paths, sections and transmission systems.[22] ITU-T Recommendation M.2101 (2000), Performance limits and objectives for bringing-into-service and maintenance of international SDH paths and multiplex sections.[23] ITU-T Recommendation M.2101.1 (1997), Performance limits for bringing-into-serviceand maintenance of international SDH paths and multiplex sections.[24] ITU-T Recommendation G.828 (2000), Error performance parameters and objectives forinternational, constant bit-rate synchronous digital paths.[25] ITU-T Recommendation I.325 (1993), Reference configurations for ISDN connection types.[26] ITU-T Recommendation I.340 (1988), ISDN connection types.[27] ITU-T Recommendation G.801 (1988), Digital transmission models.3 AbbreviationsThis Recommendation uses the following abbreviations:AAL ATM Adaptation LayerAIS Alarm Indication SignalATM Asynchronous Transfer ModeUnitAU AdministrativeBBE Background Block ErrorBBER Background Block Error RatioBIP Bit Interleaved ParityB-ISDN Broadband Integrated Services Digital NetworkCBR Constant Bit RateCEC Cell Error ControlCRC Cyclic Redundancy Check____________________2Withdrawn in June 1997.4ITU-T Rec. G.826 (12/2002)EB ErroredBlockEDC Error Detection CodeSecondES ErroredESR Errored Second RatioFAS Frame Alignment SignalHEC Header Error CheckHP Higher order PathReferencePathHRP HypotheticalHRX Hypothetical Reference ConnectionGatewayIG InternationalISDN Integrated Services Digital NetworkMonitoringISM In-ServiceLOF Loss of Frame AlignmentLOM Loss of Multiframe AlignmentLOP Loss Of PointerLOS Loss Of SignalLP Lower order PathSectionMS MultiplexN-ISDN Narrow-band Integrated Services Digital Network NTE Network Terminal EquipmentOAM Operation and MaintenanceODUk Optical Channel Data Unit-kOOS Out-of-ServiceOTN Optical Transport NetworkPDH Plesiochronous Digital HierarchyPEP Path End PointLayerPL PhysicalRDI Remote Defect IndicationREI Remote Error IndicationSDH Synchronous Digital HierarchySES Severely Errored SecondSESR Severely Errored Second RatioSTM Synchronous Transport ModuleEquipmentTE TerminalTIM Trace Identifier MismatchPathTP TransmissionUnitTU TributaryUAS Unavailable SecondUNEQ Unequipped (defect)ContainerVC Virtual4 Terms and definitionsThis Recommendation defines the following terms:4.1 hypothetical reference path: A Hypothetical Reference Path (HRP) is defined as the whole means of digital transmission of a digital signal of specified rate including the path overhead (where it exists) between equipment at which the signal originates and terminates. An end-to-end Hypothetical Reference Path spans a distance of 27 500 km.paths: A digital path may be bidirectional or unidirectional and may comprise both 4.2 digitalcustomer-owned portions and network operator-owned portions.4.2.1 PDH digital paths: With regard to PDH digital paths, ITU-T Rec. M.60 [20] applies.4.2.2 SDH digital paths: An SDH digital path is a trail carrying the SDH payload and associated overhead through the layered transport network between the terminating equipment.4.2.3 cell-based digital paths: Under study.connections: The performance objectives for digital connections are stated for each 4.3 digitaldirection of a N × 64 kbit/s circuit-switched connection (1 ≤ N ≤ 24 or ≤ 31 respectively).ITU-T Rec. I.325 [25] gives reference configurations for the ISDN connection types listed in ITU-T Rec. I.340 [26]. In the context of error performance of 64 kbit/s circuit-switched connection types and the allocation of performance to the connection elements, an all-digital hypothetical reference configuration (HRX) is given in Figure 3. It encompasses a total length of 27 500 km and is a derivative of the standard hypothetical reference configuration given in Figure 1/G.801 [27] and of the reference configuration given in Figure 3/I.325.4.4 generic definition of the block: The error performance of digital paths in this Recommendation is based upon the error performance measurement of blocks. This clause offers a generic definition of the term "block" as follows3:A block is a set of consecutive bits associated with the path; each bit belongs to one and only one block. Consecutive bits may not be contiguous in time.Table 1 specifies the recommended range of the number of bits within each block for the various bit rate ranges. Annexes B, C and D contain information on block sizes of existing system designs.4.5 Error performance events for paths44.5.1 errored block (EB): A block in which one or more bits are in error.4.5.2 errored second (ES): A one-second period with one or more errored blocks or at least one defect.4.5.3 severely errored second (SES): A one-second period which contains ≥30% errored blocks or at least one defect. SES is a subset of ES.Consecutive Severely Errored Seconds may be precursors to periods of unavailability, especially when there are no restoration/protection procedures in use. Periods of consecutive Severely Errored ____________________3Appendix II contains information on block error versus bit-error measurements.4See Appendix I, which contains a flow chart illustrating for digital paths the recognition of anomalies, defects, errored blocks, ES and SES.Seconds persisting for T seconds, where 2 ≤ T < 10 (some Network Operators refer to these events as "failures"), can have a severe impact on service, such as the disconnection of switched services. The only way this Recommendation limits the frequency of these events is through the limit for the SESR. (See Notes 1 and 2.)NOTE 1 – The defects and related performance criteria are listed in the relevant Annexes (B, C or D) for the different network fabrics PDH, SDH or cell-based.NOTE 2 – To simplify measurement processes, the defect is used in the definition of SES instead of defining SES directly in terms of severe errors affecting the path. While this approach simplifies the measurement of SES, it should be noted that there may exist error patterns of severe intensity that w ould not trigger a defect as defined in Annexes B, C and D. Thus, these would not be considered as an SES under this definition. If in the future such severe user-affecting events were found, this definition will have to be studied again.4.5.4 background block error (BBE): An errored block not occurring as part of an SES.4.6 Error performance events for connections4.6.1errored second (ES): It is a one-second period in which one or more bits are in error or during which Loss of Signal (LOS) or Alarm Indication Signal (AIS) is detected.4.6.2severely errored second (SES): It is a one-second period which has a bit-error ratio ≥ 1.10–3 or during which Loss of Signal (LOS) or Alarm Indication Signal (AIS) is detected. 4.7 Error performance parametersError performance should only be evaluated whilst the path is in the available state. For a definition of the entry/exit criteria for the unavailable state, see Annex A.4.7.1 errored second ratio (ESR): The ratio of ES to total seconds in available time during a fixed measurement interval. This parameter is applicable to both paths and connections.4.7.2 severely errored second ratio (SESR): The ratio of SES to total seconds in available time during a fixed measurement interval. This parameter is applicable to both paths and connections. 4.7.3 background block error ratio (BBER): The ratio of Background Block Errors (BBE) to total blocks in available time during a fixed measurement interval. The count of total blocks excludes all blocks during SESs. This parameter is applicable only to paths.5 The measurement of the blockClause 5 is applicable only to paths.5.1 In-service monitoring of blocksEach block is monitored by means of an inherent Error Detection Code (EDC), e.g., Bit Interleaved Parity or Cyclic Redundancy Check. The EDC bits are physically separated from the block to which they apply. It is not normally possible to determine whether a block or its controlling EDC bits are in error. If there is a discrepancy between the EDC and its controlled block, it is always assumed that the controlled block is in error.No specific EDC is given in this generic definition but it is recommended that for in-service monitoring purposes, future designs should be equipped with an EDC capability such that the probability to detect an error event is ≥90%, assuming Poisson error distribution. CRC-4 and BIP-8 are examples of EDCs currently used which fulfil this requirement.Estimation of errored blocks on an in-service basis is dependent upon the network fabric employed and the type of EDC available. Annexes B, C and D offer guidance on how in-service estimates of errored blocks can be obtained from the ISM facilities of the PDH, SDH and cell-based network fabrics respectively.。
FDA药品批准程序简介课件
Drug Application 药品申请
NDA (IND) 新药Chemistry, Manufacturing, & Controls (CMC) 化学性，生产和控制（CMC）Animal Studies 动物试验Bioavailability 生物有效性Clinical Studies 临床试验
Type of ANDA 非专利药申请的分类
No.
Type of Application申请类型
Requirement要求
1
Paragraph I CertificationI类证书
无专利存在
2
Paragraph II CertificationII类证书
专利已过期
3
Paragraph III CertificationIII类证书
Worldwide Pharmaceutical Market
by Sectors ($ Billions)
世界药品市场分类（单位：十亿美元）
2000 2001 2002 2003 2008 增长* Ethical 317.1 363.4 401.0 437.6 677.8 9.1处方药Generic 24.0 27.0 30.5 37.0 64.0 11.6非专利药OTC 70.5 73.8 78.5 82.0 101.0 4.3 Biophar- 22.1 26.3 31.0 36.5 58.6 9.0Maceutical生物药 Total 433.7 490.5 541.0 593.1 901.4 8.7 Source: IMS *Estimated from 2003 to 2008
Generic Drug Requirement
非专利药要求
全流程数据质量控制办法
全流程数据质量控制办法英文回答：End-to-End Data Quality Control Methodology.Data quality is a critical aspect of data management that ensures the accuracy, consistency, and reliability of data. A well-defined and comprehensive data quality control methodology is essential for organizations to derive meaningful insights from their data and make informed decisions. This methodology should encompass the entire data lifecycle, from data ingestion to data analysis and reporting.Data Ingestion.Data Validation: Implement data validation rules to check for missing values, data type consistency, and adherence to predefined business rules.Data Cleansing: Remove duplicate records, correct errors, and handle missing values using imputation techniques.Data Transformation: Convert data into a usable format for analysis by applying transformations such as data type conversion, normalization, and aggregation.Data Storage.Data Governance: Establish data governance policies and procedures to ensure data integrity and maintain data lineage.Data Security: Implement data security measures to protect data from unauthorized access, modification, or loss.Data Backup and Recovery: Regularly back up data to ensure data recovery in case of hardware failures or data breaches.Data Analysis and Reporting.Data Exploration: Use data analysis tools and techniques to explore data and identify patterns, trends, and outliers.Data Visualization: Create data visualizations to communicate insights effectively and identify areas for improvement.Data Reporting: Generate reports that provide timely and accurate information to stakeholders for decision-making.Data Monitoring and Improvement.Data Monitoring: Establish data monitoring mechanisms to track data quality metrics and identify data quality issues in real-time.Data Quality Improvement: Implement data quality improvement initiatives based on monitoring results tocontinuously enhance data quality.Data User Feedback: Collect feedback from data users to identify data quality issues and areas for improvement.Data Quality Management Tools.Data Quality Tools: Leverage data quality tools to automate data validation, cleansing, and transformation tasks.Data Profiling Tools: Use data profiling tools to analyze data and identify data quality issues.Data Governance Tools: Implement data governance tools to manage data lineage, enforce data policies, and ensure data security.中文回答：全流程数据质量控制方法。
翻译后的计算机化系统验证模板
Author's Signature:授权者签名Your signature indicates that this document has been prepared in accordance with existing project standards and adequately reflects the tasks and deliverables necessary for validation of the <equipment name>您的签名表明这份文件的准备符合现行项目标准并且充分反映人物u和可交付使用对<设备名称>验证的必要。
Authored By:经授权：Reviewer's Signature:审查员签名：Your signature indicates that, you have reviewed this document and that it accurately and completely reflects the tasks and deliverables necessary for validation of the <equipment name>.您的签名表明您已经审阅了这份文件，确认它精确并完全的反映任务和可交付使用对<设备名称>验证的必要。
Reviewed By:经审阅：Quality Control/Compliance Approver's Signature:质检/承认签名Your signature indicates that this document complies with <reference Validation Master Plan, company standards or guidelines>; and that the documentation and information contained herein complies with applicable regulatory, corporate, divisional/departmental requirements, and current Good Manufacturing Practices.您的签名表明这份文件符合〈证明人验证总计划，企业标准或政策〉，并且在此包含的文件和信息符合可应用的可调整的，共同的以及部门所有的／部门的要求和现行的ＧＭＰ标准。
能效设计指数EEDI功率曲线的直接计算方法
能效设计指数EEDI功率曲线的直接计算方法朱永峨;孙武;李路;温苗苗;石珣【摘要】船舶能效规则强制生效后，所有适用船舶必须满足AttainedEEDI≤Requied EEDI的条件，因此准确估算或预报功率曲线从而计算得到Attained EEDI将对适用船型具有极为重要的意义。
根据国内外关于功率-转速-航速预报的最新进展，依据螺旋桨敞水性能图谱，采用K J 系数，给出了功率曲线的直接计算方法，经实际算例验T 2/证，该方法相对传统的间接计算方法更为清晰简便，且结果准确可靠。
% After the enforcement of ship energy efficiency regulations, all applicable ships must meet the AttainedEEDI≤Required EEDI requirement. Therefore, it is of great importance to accurately estimate or predict the power curve so as to obtain the Attained EEDI for the applicable ship types. According to the latest advancement of power-rotation speed-ship speed prediction method both home and abroad, and based on the propeller open water characteristics charts, the direct power curve calculation method is proposed using the KrlJ2 coefficient. This method is validated by practical examples and is proved to be more clear, simple and accurate than conventional indirect calculation method.【期刊名称】《船舶与海洋工程》【年(卷),期】2013(000)002【总页数】5页(P62-66)【关键词】船舶能效规则;能效设计指数EEDI;功率曲线;螺旋桨敞水性能图谱;KrlJ2系数【作者】朱永峨;孙武;李路;温苗苗;石珣【作者单位】中国船级社上海规范研究所，上海 200135;中国船级社上海规范研究所，上海 200135;中国船级社上海规范研究所，上海 200135;中国船级社上海规范研究所，上海 200135;中国船级社上海规范研究所，上海 200135【正文语种】中文【中图分类】U662.20 引言2013年1月1日，船舶能效规则将对新建的散货船、气体运输船、油船、集装箱船、普通货船、冷藏货船和兼装船强制生效[1]，届时，这些船舶必须满足：式中Attained EEDI按照下式计算[2]：式中： Vr e f系指：船舶在假定无风无浪条件下75%发动机轴功率（扣除轴带发电机功率）以及最大设计装载工况（装载量）下在深水中的航速（kn）。
恶劣海况下维持操纵性的最小推进功率临时导则浅析
恶劣海况下维持操纵性的最小推进功率临时导则浅析沈文娜【摘要】MEPC.232（65）决议《2013恶劣海况下维持操纵性的最小推进功率临时导则》从两个不同等级对船舶装机功率进行评估，以确保船舶的装机功率能维持船舶在恶劣海况下的操纵性。
文章以载重量118 000 t的散货船为例，对该导则进行了阐述和分析。
%From two different assessment levels, evaluation has been carried out in order to assure the suffcient installed propulsion power to maintain the maneuverability of ships in adverse conditions, as speciifed in“2013 Interim guidelines for determining the minimum propulsion power to maintain the maneuverability of ships in adverse conditions (Resolu tion MEPC.232 (65))”. Taking a 118 000 DWT bulk cargo vessel, the interim guidelines have been expounded and analyzed in this paper.【期刊名称】《船舶》【年(卷),期】2014(000)006【总页数】7页(P40-46)【关键词】恶劣海况;操纵性;最小推进功率;评估【作者】沈文娜【作者单位】上海臻元船舶科技有限公司上海200052【正文语种】中文【中图分类】U662.1引言2011年7月11日～15日，国际海事组织（IMO）在英国伦敦总部召开了海上环境保护委员会MEPC第62届会议，并以MEPC.203（62）决议的形式通过了包括EEDI在内的国际防止船舶污染海洋公约（MARPOL）附则VI有关船舶能效规则的修正法案，即增加第四章关于新船能效设计指数（Energy Efficiency Design Index，简称EEDI）和船舶能效管理计划（SEEMP）要求，于2013年1月1日正式生效。
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7.5 – 02 05 – 06 Page 2 of 5
Effective Date Revision
1999
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High Speed Marine Vehicles: Structural Loads
1 PURPOSE OF PROCEDURE
To describe model test for prediction structural loads on high speed marine vehicles.
2.2 Structural Loads
The dimensioning of large high speed vehicles demands a knowledge and methods to determine the limiting environmental loads, operational aspects and structural strength. To achieve good design load predictions, appropriate model test techniques must be developed. Model tests are also required for verification and calibration of theoretical methods and numerical codes.
Effective Date Revision
1999
00
2.2.1 Local Loads
For the local problem the slamming force is the most important load contribution. Firstly, one should not consider point pressures, but rather forces on a sensibly chosen area, e.g. a single plating field (Carcaterra & Ciappi, 1998, Carcaterra et al., 1999). The dynamic behaviour of the elastic plate is governed by the structural properties of the plating (including longitudinal stiffeners between two transverse frames). The global response of the ship will serve as input to the problem defining the relative speed and orientation of the local area of interest during the impact with the waves. For flat-bottom slamming, and wet-deck slamming of multi-hulls, hydro elasticity is crucial for the magnitude of the slamming loads. Testing is done either with the dynamic behaviour correctly modelled, or the results are used solely to document the occurrence of slamming, not the magnitude of the forces. For bow slamming, and slamming on surfaces with a dead rise angle of more than approximately 15°, hydroelastic effects are less important and testing can be performed without modelling the local structural dynamics (Faltinsen, 1998). Forces can be measured by means of a suitably sized panel mounted on a strain-gauge arrangement. The panel should be stiffly mounted in order to avoid artificial hydroelastic effects.
The most simple method for measurement of slamming with modelled structural dynamics is with a strain-gauge mounted stiff panel where stiffness and mass are correctly scaled to yield the correct frequency of the first eigenmode. A more correct method is to model a suitable part of the hull plating correctly (mass and stiffness). An even more complete, but
1999
00
Table of Contents
1 PURPOSE OF PROCEDURE……...…2
2 TEST TECHNIQUES AND PROCEDURES…………………….…..2
2.1 General.............................................2 2.2 Structural Loads .............................2
ITTC - Recommended Procedures and Guidelines
Testing and Extrapolation Methods High Speed Marine Vehicles Structural Loads
7.5 – 02 05 – 06 Page 3 of 5
The test types are listed in order of how often they are carried out according to the questionnaire survey. Resistance tests are the most common by a large margin. Many of the issues
Resistance (Procedure 7.5-02-05-01) Propulsion (Procedure 7.5-02-05-02) Sea Keeping (Procedure 7.5-02-05-04) Manoeuvring (Procedure 7.5-02-05-05) Structural Loads (Procedure 7.5-02-05-06) Dynamic Instability (Procedure 7.5-05-02-07)
Structural loads can be divided into hydroelastic problems and non-hydroelastic problems. The former requires the structural dynamics to be modelled correctly. That means that not only the mass distribution, but also the stiffness must be scaled. The scaling relations are:
ITTC - Recommended Procedures and Guidelines
Testing and Extrapolation Methods High Speed Marine Vehicles Structural Loads
7.5 – 02 05 – 06 Page 1 of 5
Effective Date Revision
2.2.1 Local Loads ...................................3 2.2.2 Global Loads .................................4 3 PARAMETERS………………………..5
3.1 Parant ............................................5
Prepared HSMV Committee of 22nd ITTC
Date
Approved Date
22nd ITTC 1999
ITTC - Recommended Procedures and Guidelines
Testing and Extrapolation Methods High Speed Marine Vehicles Structural Loads
2 TEST TECHNIQUES AND PROCEDURES
2.1 General
The review of HSMV model testing technology conducted by the 16th ITTC was organised in order of HSMV type: SWATH, semidisplacement, planing, hydrofoil, SES and ACV. For each type of craft a summary was given for different areas of technology such as resistance, sea keeping, manoeuvring, performance and propulsor. Upon reviewing this work, the Specialist Committee concluded that the recommended codes of practice would be less repetitive if they were arranged in order of test type rather than HSMV type. The following main test types were identified: