欧盟工艺验证报告 中英文翻译
Annex 15Qualification and Validation(附件15确认与验证)正式版中英文对照
上海万逸医药科技有限公司刘伟强译Ref. Ares(2015)1380025 - 30/03/2015EUROPEAN COMMISSIONDIRECTORATE-GENERAL FOR HEALTH AND FOOD SAFETYMedicinal Products – Quality, Safety and EfficacyBrussels, 30 March 2015EudraLexVolume 4EU Guidelines forGood Manufacturing Practice forMedicinal Products for Human and Veterinary Use欧盟人用及兽用药品GMP指导原则Annex 15: Qualification and Validation附件15：确认与验证Legal basis for publishing the detailed guidelines: Article 47 of Directive 2001/83/ECon the Community code relating to medicinal products for human use and Article 51 of Directive 2001/82/EC on the Community code relating to veterinary medicinal products.This document provides guidance for the interpretation of the principles and guidelinesof good manufacturing practice (GMP) for medicinal products as laid down in Directive2003/94/EC for medicinal products for human use and Directive 91/412/EEC for veterinary use.Status of the document: Revision文件状态：修订Reasons for changes: Since Annex 15 was published in 2001 the manufacturing and regulatory environment has changed significantly and an update is required to this Annexto reflect this changed environment. This revision to Annex 15 takes into account changesto other sections of the EudraLex, Volume 4, Part I, relationship to Part II, Annex11, ICH Q8, Q9, Q10 and Q11, QWP guidance on process validation, and changes in manufacturing technology.变更原因：附录15至2001年颁布以来，制造业和法规环境发生了显著变化，因此需要更新附录以反应这些环境的变化，附录15的修订还考虑到了欧盟药品监管法规（Eudralex）第四卷第一部分、第二部分有关内容、附录11、ICH Q8、Q9、Q19和Q11、欧盟药品质量工作组（QWP）工艺验证指南的变更以及制造技术变化等因素。
欧盟GMP附录15确认和验证中英文新版
欧盟GMP附录15确认和验证欧盟GMP附录15确认和验证ANNEX 15 附件15Qualification and Validation确认和验证Table of Contents 目录1. Qualification and Validation 确认和验证2. Planning for Validation 验证计划3. Documentation 文件4. Qualification 确认5. Process Validation 工艺验证6. Cleaning Validation 清洁验证7. Change Control 变更控制8. Revalidation 再验证9. Glossary 术语表Qualification and Validation 确认和验证Principle 原理1.This Annex describes the principles of qualification and validation which are applicable to the manufacture of medicinal products. It is a requirement of GMP that manufacturers identify what validation work is needed to prove control of the critical aspects of their particular operations. Significant changes to the facilities, the equipment and the processes, which may affect the quality of the product, should be validated. A risk assessment approach should be used to determine the scope and extent of validation.1.本附件描述了确认和验证的原理，适用于医药产品的生产者。
EU GMP 附录15：确认与验证(中英对照)
欧盟工艺验证报告(中英文翻译)
VALIDATION REPORT APPROVAL验证报告批准
Activity 活动
Prepared By 制
定
Reviewed By 审
核
Name 姓名 PRAKASH.K.C
AMARESH.C
Designation 职务
Executive主 管
Department部
Batch No批号. 907001 (Lot - I) (10 Minutes)
Sample Location
样品位置
Top 顶部
Middle Left 中左
Middle 中部
Middle Right 中右
Bottom 底部
A.R.NO.: BPV 90066
Mean 平均
RSD %
Assay in mg
PROCESS VALIDATION SUMMARY REPORT 工艺验证总结报告
FOR MANUFACTURING PROCESS OF
Paracetamol tablets 500 mg 对乙酰氨基酚500mg片生产工艺
Product
BAFNA PHARMACEUTICALS LIMTED PROCESS VALIDATION SUMMARY REPORT
PAGE NO. 1 2 3 4 4 4
5-6 7
8 - 10 11 - 14 15 - 24 25 - 26 27 - 28
29 30 – 33
34 35
NO.OF PAGES 1 1 1 1 1 1 2 1 3 4 10 2 2 1 4 1 1
Product
BAFNA PHARMACEUTICALS LIMTED PROCESS VALIDATION SUMMARY REPORT
20100731 欧盟API GMP 中英文对照 CX 20110112
EUROPEAN COMMISSION 欧盟委员会ENTERPRISE AND INDUSTRY DIRECTORATE-GENERAL 企业与工业管理局Consumer goods 消费品Pharmaceuticals 药品Brussels, 03 February 2010 布鲁塞尔2010.02.03ENTR/F/2/AM/an D(2010) 3374EudraLex（European Union Law On drug regulatory affairs）欧盟药品法规The Rules Governing Medicinal Products in the European Union欧盟医药产品管理规则Volume 4卷4Good Manufacturing Practice良好生产规范Medicinal Products for Human and Veterinary Use人用和兽用医药产品Part II: Basic Requirements for Active Substances used as Starting Materials 第二部分：作为起始物料的原料药的基本要求Table of Contents目录1 Introduction1简介1.1 Objective1.1目的1.2 Regulatory Applicability1.2法规适用性1.3 Scope1.3范围2 Quality Management2质量管理2.1 Principles2.1原则2.2 Quality Risk Management2.2质量风险管理2.3 Responsibilities of the Quality Unit(s) 2.3质量部门的职责2.4 Responsibility for Production Activities 2.4生产活动的职责2.5 Internal Audits (Self-Inspection)2.5内部审计（自检）2.6 Product Quality Review2.6产品质量回顾3 Personnel3 人员3.1 Personnel Qualifications3.1 人员资质3.2 Personnel Hygiene3.2 人员卫生3.3 Consultants3.3 顾问4 Buildings and Facilities4 厂房设施4.1 Design and Construction4.1 设计和建造4.2 Utilities4.2 公用工程4.3 Water4.3 水4.4 Containment4.4 限制4.5 Lighting4.5 照明4.6 Sewage and Refuse4.6 废水废物4.7 Sanitation and Maintenance4.7 公共卫生及保养5 Process Equipment5 工艺设备5.1 Design and Construction5.1 设计和建造5.2 Equipment Maintenance and Cleaning5.2 设备的保养和清洁5.3 Calibration5.3 校验5.4 Computerized Systems5.4 计算机系统6 Documentation and Records6 文件和记录6.1 Documentation System and Specifications6.1 文件系统与规格标准6.2 Equipment Cleaning and Use Record6.2 设备清洁和使用记录6.3 Records of Raw Materials, Intermediates, API Labelling and Packaging Materials 6.3 原料、中间产品、原料药的标签和包装材料的记录6.4 Master Production Instructions (Master Production and Control Records)6.4 生产指令（生产和控制记录）6.5 Batch Production Records (Batch Production and Control Records)6.5批生产记录（批生产和控制记录）6.6 Laboratory Control Records6.6 实验室控制记录（批检验记录）6.7 Batch Production Record Review6.7批生产记录审核7 Materials Management7 物料管理7.1 General Controls7.1 控制通则7.2 Receipt and Quarantine7.2 接受和待检7.3 Sampling and Testing of Incoming Production Materials7.3 到货物料的取样和检测7.4 Storage7.4 贮存7.5 Re-evaluation7.5 再评估8 Production and In-Process Controls8 生产和过程控制8.1 Production Operations8.1 生产操作8.2 Time Limits8.2 时间限制8.3 In-process Sampling and Controls8.3 中控取样和控制8.4 Blending Batches of Intermediates or APIs8.4 中间产品和原料药的混批8.5 Contamination Control8.5 污染控制9 Packaging and Identification Labelling of APIs and Intermediates 9 中间产品和原料药的包装和贴签9.1 General9.1 总则9.2 Packaging Materials9.2 包装材料9.3 Label Issuance and Control9.3 标签放行和控制9.4 Packaging and Labelling Operations9.4 包装和贴签操作10 Storage and Distribution10 贮存和销售10.1 Warehousing Procedures10.1 入库程序10.2 Distribution Procedures10.2 销售程序11 Laboratory Controls11 实验室控制11.1 General Controls11.1 控制通则11.2 Testing of Intermediates and APIs11.2 中间产品和原料药的检测11.3 Validation of Analytical Procedures11.3 分析方法的验证11.4 Certificates of Analysis11.4 分析报告11.5 Stability Monitoring of APIs11.5 原料药的稳定性监测11.6 Expiry and Retest Dating11.6 失效和复检日期11.7 Reserve/Retention Samples11.7 留样12 Validation12 验证12.1 Validation Policy12.1 验证方针12.2 Validation Documentation12.2 验证文件12.3 Qualification12.3 确认12.4 Approaches to Process Validation12.4 工艺验证方法12.5 Process Validation Program12.5 工艺验证计划12.6 Periodic Review of Validated Systems12.6 验证系统的定期审核12.7 Cleaning Validation12.7 清洁验证12.8 Validation of Analytical Methods12.8 分析方法验证13 Change Control13 变更控制14 Rejection and Reuse of Materials14 物料的拒收和再利用14.1 Rejection14.1 拒收14.2 Reprocessing14.2 返工14.3 Reworking14.3 重新加工14.4 Recovery of Materials and Solvents14.4 物料和溶剂的回收利用14.5 Returns14.5 退回15 Complaints and Recalls15 投诉和召回16 Contract Manufacturers (including Laboratories)16 合同生产企业（包含实验室）17 Agents, Brokers, Traders, Distributors, Repackers, and Relabellers 17 代理商、经纪商、贸易商、经销商、重新包装商和重新贴签商17.1 Applicability17.1 适用性17.2 Traceability of Distributed APIs and Intermediates17.2 已销售中间产品和原料药的追踪17.3 Quality Management17.3 质量管理17.4 Repackaging, Relabelling and Holding of APIs and Intermediates 17.4 中间产品和原料药的重新包装、重新贴签和处理17.5 Stability17.5 稳定性17.6 Transfer of Information17.6 信息的传输17.7 Handling of Complaints and Recalls17.7 投诉和召回的处理17.8 Handling of Returns17.8 退货的处理18 Specific Guidance for APIs Manufactured by Cell Culture/Fermentation 18 用于细胞培养/发酵而得原料药的特殊指南18.1 General18.1 总则18.2 Cell Bank Maintenance and Recordkeeping18.2 细胞库的维护和记录保存18.3 Cell Culture/Fermentation18.3 细胞培养/发酵18.4 Harvesting, Isolation, and Purification18.4 收获、分离和精制18.5 Viral Removal/Inactivation Steps18.5 病毒除去/灭火步骤19 APIs for Use in Clinical Trials19 用于临床试验的原料药19.1 General19.1 总则19.2 Quality19.2 质量19.3 Equipment and Facilities19.3 设备设施19.4 Control of Raw Materials19.4 原料的控制19.5 Production19.5 生产19.6 Validation19.6 验证19.7 Changes19.7 变更19.8 Laboratory Controls19.8 实验室控制19.9 Documentation19.9 文件20 Glossary20 词汇表1 Introduction1 介绍This guideline was published in November 2000 as Annex 18 to the GMP Guide reflecting the EU’s agreement to ICH Q7A and has been used by manufacturers and GMP inspectorates on a voluntary basis. Article 46 (f) of Directive 2001/83/EC and Article 50 (f) of Directive 2001/82/EC; as amended by Directives 2004/27/EC and 2004/28/EC respectively, place new obligations on manufacturing authorisation holders to use only active substances that have been manufactured in accordance with Good Manufacturing Practice for starting materials. The directives go on to say that the principles of Good Manufacturing Practice for active substances are to be adopted as detailed guidelines. Member States have agreed that the text of former Annex 18 should form the basis of the detailed guidelines to create Part II of the GMP Guide.本指南已经在2000年11月以GMP指南附录18的形式公布过，它反应了欧盟对ICH Q7A的认可以，该指南已经被生产商和GMP检查员在自愿的原则下所使用。
检验报告常用术语中英文对照
检验报告常用术语中英文对照序号 English Chinese 序号 English Chinese 1bend 弯曲 102shrink mark收缩纹2broken 破烂 103stress mark顶白印3broken label标贴烂 104thin spray喷油过薄4broken screw缧丝断 105uneven coation涂色不圴5burn mark烧痕 106uneven spray喷油不均匀6burr 毛边 107uneven surface高低落差过大 7carton broken外箱烂108untrimmed thread线头过长8color deviatiion色差过大 109water mark水渍9damage 损坏 110wrinkle 皱纹10deform 变形 111wrong assortment错混装11foreign tape纸屑 112wrong color错颜色12dent mark凹陷 113wrong labelling错标贴13dirt mark污渍 114wrong packing错包装14flash 披锋 115wrong products错货品15flow mark胶料注塑纹 116wrong sewing label错缝合标贴16foreign material外物(就是脏东西 117foreign stuffing线头17gate mark水口修不好 118missing letter缺字18glue mark胶水渍 119missing segment缺字划19hole misalignment孔位不正 120part detach配件甩掉20illegible letter字型模糊不清 121part loose配件松21label peel off标贴脱落 122screw not tight缧丝未收紧22label peel up标贴浮起/分离 123uneven table surface台面不平23large gap间隙过大 124wrong letter错字24missing glue漏胶水 125wrong parts错配件25missing label漏标贴 126bent insert纸卡变形26mould 发霉 127air leakage漏气27no glue无胶水 128cannot assembly组装不成功28oil mark油渍 129dim light灯光过暗29oxidization 氧化 130distortion 失真30paint mark补油不良 131intermittent function间断没功能31paint mark喷油渍 132missing parts漏配件32poor coating露底色 133missing products漏货品33poor fitting接合不良 134narrow goal socket袋口过窄34poor glue黏合不良 135no light无灯光35poor hot stamp烫金不良 136no sound无声音36poor parting line接合边位修不好 137noise 噪声37poor printing印刷不良 138non function无功能38poor seal封合位不良 139poor packing包装不良39poor sewing缝合不良 140poor soldering焊接不良40poor silk screen printing丝印不良 141water leakage漏水41poor spray喷油不良 142weak soung声音过弱42poor stitching缝合孔位过大 143wire damage电线烂43poor tampo printing移印不良 144wire exposed电线外露44poor trimmimg修剪不良 145wrong function错功能45poor trimmimg胶边位修不好 146wrong soung错声音46base 底座 147cracking 裂纹47rough edge边位粗糙 148blood mark血渍48rough surface表面粗糙 149high pole test failure电气高压测试失败 49rust mark生锈 150insect 昆虫50scratch mark花痕 151sharp edge利边 , 毛刺51screw slip缧丝滑牙 152sharp point尖点52instruction sheet came off缺少说明书 153sharp point利角53hard to assembly装配困难 154short circuit漏电 / 短路 54poorfunction功能不良 155damaged window sheet彩盒损坏55too loose太松 156label misalinged标贴贴倒56scratch mark刮花 157dislocated 移位57color deviation颜色有差别,色差 158poor label sticking贴纸不良58electro-plating yellownish电镀变黄 159poor molding注塑不良59electro-plating peel off电镀脱落 160poor packing包装不良60electro-plating abrase电镀擦花 161poor electro-plating电镀不良61tempo incomplete移印不完整 162missing Part缺少附件62tempo off position移印移位 163oversize 尺寸过大63paint abrase喷油擦花 164packing damaged包装损坏64electro-plating rainbow电镀彩虹印 165poor bewing车缝不良65electro-plating shadow电镀阴阳色 166poor soldering焊接不良66electro-plating black mark电镀发黑 167poor shrink wrap收缩包装不良67oxidatton 氧化 168poor tampo移印不良68inner carton内盒 169seam open车缝开口69gift box彩盒 170seam torn车缝穿洞70ejector mark顶针位 171stripping screw螺丝打滑71flow mark流水痕 172wrong instruction sheet 说明书错误Defect name72flow line流水纹 173blister 吸塑73fold mark折痕 174FOLD MARK ON GIFT彩盒折痕74white mark发白 175GIFT BOX DEFORM彩盒压变形 75poor transparency透明度不良 176BLISTER DEFORM吸塑变形76sink mark凹痕 177BLISTER CRACK吸塑裂77poor contact接触不良 178BLISTER POOR HEAT SEALING吸塑不良78loosen 脱落 179gift box unseal彩盒无封口贴 79air-bubble on painting漆上有气泡180poor silk sckeen prining印刷不良 80painting scratched油漆刮花 181over plating电镀过多 81painting peeled off油漆脱落 182under plating电镀不足82pough surface painting油漆面粗糙 183color mismatch颜色不配对83rivet 铆钉 184color misalignment颜色不配对 84blister 泡盒 185color deviation颜色有差别,色差 85rust mark锈迹 186electro-plating yellownish电镀变黄86flow mark流水痕 187electro-plating peel off电镀脱落87flow line流水纹 188electro-plating abrase电镀擦花88fold mark折痕 189tempo incomplete移印不完整 89white mark发白 190tempo off position移印移位90poor transparency透明度不良 191paint abrase喷油擦花91sink mark凹痕 192electro-plating rainbow电镀彩虹印 92poorcontact接触不良 193electro-plating shadow电镀阴阳色 93loosen 脱落194electro-plating black mark电镀发黑94air-bubble on painting漆上有气泡 195oxidatton 氧化95painting scratched油漆刮花 196inner carton内盒96painting peeled off油漆脱落 197gift box彩盒97pough surface painting油漆面粗糙 198ejector mark顶针位98rivet 铆钉 199rust mark锈迹99blister 泡盒 200fixed sleeve 固定套100spring 弹簧 201Cover Plate面板101Lining 内衬 202Slide tube伸缩管203Stem Extension延长杆。
欧洲药典EP8.0 2.6.1无菌检验 sterility中英文翻译
2.6.1. STERILITY2.6.1 无菌检查法The test is applied to substances, preparations or articles which, according to the Pharmacopoeia, are required to be sterile. However, a satisfactory result only indicates that no contaminating micro-organism has been found in the sample examined in the conditions of the test.本检查方法适用于按照药典要求应当无菌的原料、制剂或其他物质。
但是，如果按照本无菌检查法的结果符合要求，仅表明在该检查条件下未发现微生物污染。
PRECAUTIONS AGAINST MICROBIAL CONTAMINATION微生物污染防范The test for sterility is carried out under aseptic conditions. In order to achieve such conditions, the test environment has to be adapted to the way in which the sterility test is performed. The precautions taken to avoid contamination are such that they do not affect any micro-organisms which are to be revealed in the test. The working conditions in which the tests are performed are monitored regularly by appropriate sampling of the working area and by carrying out appropriate controls.无菌检测试验应在无菌的条件下进行。
2012年某公司无菌制剂欧盟GMP检查缺陷-中英对照
Deficiencies1、Samples for the release testing (vial filling process) have to be traceable to the sampling time and should be representative for the beginning, middle and end of the filling process. The samples taken have to be tested individuallyand not as a composite sample.用于放行检测的样品（小瓶灌装工艺）必须追溯到取样时间，应该对灌装工艺的开始、中间和结束时间点具有代表性。
必须单独分别检测这些样品，而不能作为组合样品进行检验。
2、During the validation of the newly established Turbometric Endotoxin determination as per EP (Validation plan and report from 29.02.2012) USP Endotoxin standards instead of EP standards were used. A comparison or justification was not performed. During the reviewed Rubber Stopper release testing the USP Endotoxin Standard was used.在根据EP新建立的Turbometric内毒素检测方法验证过程中，采用了USP方法，而不是EP方法。
没有进行对比和论证。
在审核胶塞放行测试中，采用了USP内毒素测试方法。
3. In the master batch records some references to SOPs are needed e.g. the performance of specific environmental monitoring activities were missing.在主批记录中，很多和SOP相关参考文件需要注明，例如特定环境监控活动的表现没有注明。
欧版GMPC-中文版手工翻译
优质化妆产品生产指导（GMPC）保护消费者健康目录介绍1.术语2.质量体系2.1介绍2.2员工2.3建筑2.4设备2.5程序及流程2.5.1程序和指引2.5.2流程3.采购3.1介绍3.2合同要求3.3采购文件4.生产4.1介绍4.2进场产品接收4.2.1原材，包装材料，散装产品4.2.2水4.2.3仓储4.3生产过程4.3.1准备4.3.2实际生产过程4.3.3待包装产品储存4.4包装4.5成品储存5.转包生产6.质量管理6.1介绍6.2质量控制6.2.1介绍6.2.2设备和试剂6.2.3控制活动6.2.4控制记录6.2.5留样和样品库6.3监控和数据使用6.4文件控制6.4.1跟踪文件6.4.2文件管理6.5不一致产品管理6.6卫生6.6.1工厂卫生6.6.2个人卫生6.7审核参考文献一、专业术语批次：被一个或多个操作所采用的某一原材料，包装材料或产品的指定的量。
他们被认为是一致的。
在线上生产的情况中，一个批次可以是在一段给定时间内一个产品的量。
二、质量体系2.1 介绍对于想达成其质量目标的企业，它应设计，应用和维护适应生产活动，产品特性和由公司高层支持的文件质量体系。
在生产层面，这个体系包括组织结构，职责和涉及质量管理的可用的资源，程序和流程。
组织结构应清晰设定以搞清楚企业的组织和运作。
它应包括企业规模和产品多样化程度。
企业应当在员工，场所，机器，设备和管理上有着合适和充足的资源。
质量体系要求对违规的分析，整改措施的落实，以及确保改进和足够的监管。
2.2 员工组织结构应是的在不同活动领域中有足够的员工层级：员工应具有技术，经验，适应他们呢职责和工作的能力和积极性。
为了这个目的，所有组织内各阶层员工的培训需求应当被识别并制定相应的培训计划。
员工应当：●知道他们在组织结构中的位置●知道他们的职责和任务●能接触到跟他们负责的生产环节相关的指引，信息和数据●持续被鼓励报告可能在各个生产环节出现的违规和其他不一致情况●遵守个人卫生要求，遵守有关工作和操作方法的指引能找到员工可以替代空缺很理想应采取所有必要措施来提高所有员工的技术和积极性：●培训：企业应建立和完成适合涉及执行不同生产操作（称重，执行，维护，行业卫生，生产过程中验证等）的任务和职责的培训活动。
欧盟工艺验证指南Note on Guidance for Process Validation
The European Agency for the Evaluation of Medicinal Products7Westferry Circus,Canary Wharf,London,E144HB,UKLondon,1March 2001CPMP/QWP/848/96EMEA/CVMP/598/99COMMITTEE FOR PROPRIETARY MEDICINAL PRODUCTS (CPMP)COMMITTEE FOR VETERINARY MEDICINAL PRODUCTS (CVMP)NOTE FOR GUIDANCE ON PROCESS VALIDATION DISCUSSION IN THE QUALITY WORKING PARTY (QWP)June 1997,October 1998,January 1999,June 1999TRANSMISSION TO THE CPMP/CVMPSeptember 1999RELEASE FOR CONSULTATIONSeptember 1999DEADLINE FOR COMMENTSMarch 2000ADOPTION BY CPMP/CVMPFebruary 2001DATE FOR COMING INTO OPERATION September 2001NOTE FOR GUIDANCE ON PROCESS VALIDATION1.INTRODUCTIONValidation is the act of demonstrating and documenting that a procedure operates effectively. Process validation is the means of ensuring and providing documentary evidence that processes (within their specified design parameters)are capable of consistently producing a finished product of the required quality.In terms of pharmaceutical process validation it is intended that the combination of the guidance provided in the Note for guidance on Development Pharmaceutics with this guidance should cover all the critical elements in a manufacturing process for a pharmaceutical product,from development of the process through to final validation at the production scale.While it is recognised that the term validation is intended to apply to the final verification at the production scale(typically3production batches),the guidance presented here is intended to encompass the information that should routinely be included in the marketing authorisation application.Since it is essential that only valid manufacturing processes be used,it is increasingly expected that data should be submitted in the application for marketing authorisation demonstrating the validity of a given process.In this regard it is clear that compliance with the finished product specification alone may be insufficient to demonstrate to the reviewer of the dossier that the processes are valid and that the manufacturer has full control over the manufacturing process. Thus in addition to batch analysis it may well be necessary to conduct further testing depending upon the complexity of the product and of the manufacturing process.This note for guidance is intended to demonstrate and standardise the data that should be routinely included in the marketing authorisation dossier describing the evaluation or validation of the manufacturing process and distinguish them from those validation data which more properly fall under the remit of GMP Inspection.Scientific evaluation of the data on the manufacturing process and the control procedures described in the dossier is routinely carried out by the assessor prior to granting of the marketing authorisation.It is recognised that at the time of submission of a marketing authorisation dossier manufacturers may not have completed formal validation studies on production scale batches. However the guideline will attempt to link the development and evaluation studies conducted on laboratory and pilot scale batches,process development and optimisation together with the production scale data(if available)or consideration of an appropriate process validation scheme to be applied to production scale batches of the product.This scheme will form part of the application for marketing authorisation and should outline the formal studies planned for the production scale batches(normally three)before the product is placed on the market.The results of these studies should be available for verification by the supervisory authority according to national procedure.Thus the progress from pre-formulation→formulation→pilot manufacture→industrial scale manufacture should be shown in the Marketing Authorisation Application dossier to be logical, reasoned and continuous.2.SCOPEThis Note for Guidance is intended to give advice to the applicant for marketing authorisation in relation to studies to evaluate the manufacturing process and/or data which need to be generated to validate the processes used for the manufacture of the finished product.In this regard,it is intended to supplement information requested and thereby provide a formal link between the related guidelines on development pharmaceutics,manufacture of the finisheddose form and specification and control tests on the finished product.The note for guidance is intended to apply to data generated to evaluate or validate the manufacturing process of the intended commercial dosage form only-it is not directly relevant to the manufacture of the active substance or other starting materials,although it may contain information useful for such activities.It is not intended to apply to products of biotechnological or biological origin including products extracted from human or animal tissues or fluids since these processes are themselves very complex in nature and have an inherent variability which generally require the submission of more extensive validation data. Nevertheless,the principles and practices outlined in this guideline may well also be useful in such more complex operations.The note for guidance also applies to products manufactured outside the European Union to help to provide the reassurance necessary to demonstrate the suitability of the quality of the product for marketing within the E.U.The guideline will also address issues such as additional data required on change of manufacturing site or change of process once marketing has been approved.3.RELATIONSHIPS BETWEEN PRODUCT DEVELOPMENT,MANUFACTURING PROCESSES,PRODUCT SPECIFICATIONS AND VALIDATION3.1Relationship between development studies and process validation dataIt is expected that during the development stage,the manufacturer of the product should gain sufficient information about the behaviour and the physical and chemical properties of the drug substance,the composition of the product in terms of active ingredient(s)and key excipients and the manufacturing process to clearly define the critical steps in the manufacturing process. Critical parameters of the product should be identified at an early stage;for example the dissolution rate of an active substance and the effect of the presence,type and amount of lubricant.Information generated during the development stage should thus be used to identify and evaluate the critical pharmaceutical process parameters which may need to be examined and possibly controlled in order to ensure batch to batch reproducibility.In order to define these critical parameters it may be necessary to challenge the process by making deliberate changes to demonstrate the robustness of the process and define the limits of tolerance.Such parameters will vary depending upon the nature of the product,the composition and the proposed method of manufacture,as highlighted in the note for guidance“Development Pharmaceutics”.The choice of the method of manufacture should be properly justified in the context of the development data obtained.3.2Relationship between method of manufacture and process validation dataHaving defined and justified a particular method of manufacture based on a consideration of the physical and chemical properties of the active ingredient,the key excipients,the choice of formulation and the impact of processing on the product quality and stability,the applicant should progress to fully describe the manufacturing process(see Note for guidance on Manufacture of the finished dosage form).Such a description should address also the need and value of in-process controls and the manufacturer’s approach to process optimisation.The evaluation of the process should provide adequate proof of the feasibility of the process at the production scale thereby ensuring the consistent quality of the product in line with the approved specification.3.3Relationship between Process Validation and the Specification of the FinishedProductThe ICH guideline Q6A Specifications for new drug substances and products permits skip lot testing,i.e.replacement of routine verification of certain tests on a batch by batch basis.In addition,data generated through process evaluation or validation can be used to justify why certain test need not be conducted routinely on the finished product at release.In such cases the applicant must explain and justify such an approach in Part IIE of the dossier and in the expert report and should cross-refer to this approach in Part IIB3.The appropriate veterinary guidance on Specifications should also be consulted.4.DATA SUBMISSIONValidation data should be generated for all products to demonstrate the adequacy of the manufacturing process.It is recognised that,at the time of submission,process validation data may not always be available.Nevertheless it is essential that valid manufacturing processes are always utilised.Validation data should be held at the manufacturing location and made available for verification by the supervisory authority according to national procedure.Where the manufacturing process utilises a non-standard method of manufacture,data demonstrating the validity of that method should be submitted in the marketing authorisation dossier.These data should be submitted from all sites where production is intended to take place.The amount of data submitted in the dossier will depend to a certain extent on the nature and complexity of the product and the active ingredient,and the complexity,type and stage of development of the manufacturing process.Data will be generated on different scales as the manufacturing process is developed.4.1Laboratory Scale BatchesThese are produced at the research and early development laboratory stage;they may be of very small size(e.g.100-1000x less than production scale).These batches may find many uses,for example to support formulation and packaging development,clinical and/or pre-clinical studies.The data derived from these batches assist in the evaluation and definition of critical product performance characteristics and thereby enables the choice of the appropriate manufacturing process.Such experiments should be described in the section‘Development Pharmaceutics’. (Part IIA.4)4.2Pilot BatchesThese may be used in the process development or optimisation stage,may be used to support formal stability studies and also to support pre-clinical and clinical evaluation.Pilot batch size should correspond to at least10%of the production scale batch,i.e.such that the multiplication factor for the scale-up does not exceed10.For oral solid dosage forms this size should generally be10%of production scale or100,000 units whichever is the greater1.The role of pilot scale batches is to provide data predictive of the production scale product.It may be necessary to further develop and optimise the manufacturing process using pilot scale1In the case of veterinary medicinal products,the minimum pilot batch size may be smaller than100,000units where justified.batches.The pilot batch therefore provides the link between process development and industrial production of the product.The purpose of the pilot batch is to challenge the method proposed for routine production,i.e. to analyse and evaluate:-the difficulties and critical points of the manufacturing process-the apparatus and methods most appropriate to large-scale production.To summarise,the production of pilot batches should provide a high level of assurance that the product and process will be feasible on an industrial scale.4.3Production-scale BatchesThese batches are of the size which will be produced during the routine marketing of the product.Data on production scale batches may not always be available prior to granting marketing authorisation.Where production scale data are not available or presented at the time of submission,the two stage approach outlined below should be followed.First a thorough evaluation and characterisation of the critical process parameters at laboratory or pilot scale,followed by a formal validation programme on production scale batches for which the validation scheme(as outlined in Annex I)has been described to the regulatory authorities in the dossier(MAA)and for which the results can be subsequently verified by the supervising authority according to national procedure.4.4Data requirementsSince it is not generally considered useful to conduct full validation studies on pilot scale batches,the validation scheme outlined in Annex I should be completed for each product for subsequent verification at the production scale.In certain cases however,it is considered necessary to provide production scale validation data in the marketing authorisation dossier,e.g.in those circumstances where the applicant is proposing a non-standard method of manufacture,where pilot scale data may not be predictive of production scale or for specialised products such as certain modified release preparations (for medicinal products for human use,see Note for guidance on Modified release products). Non standard methods of manufacture would include non-standard methods of sterilisation and,aseptic processing.In some cases lyophilisation,micro-encapsulation,certain mixing and coating processes and other specialised processes may also be considered non-standard. Where non-standard sterilisation methods or aseptic processing are employed,data should be provided on three consecutive batches at production scale prior to approval.For other specialised non-standard processes,data on1or2production scale batches may suffice where these are supported by pilot scale batches,and by a history of consistent manufacture of products by essentially equivalent processes.The studies should address those phases of manufacture,in particular the critical phases which would not necessarily be adequately addressed by application of the finished product specification alone,by conducting additional testing as necessary.A justification for the chosen process validation scheme and the verification strategy should be presented in the pharmaceutical expert report.5.SCALE-UPIn order to avoid the repetition of lengthy and costly tests,it is necessary to gather information during properly designed development and process optimisation studies,when scaling up fromlaboratory through pilot to production scale.Such information provides the basis for justification that scale-up can be achieved without a consequent loss in quality.Those parts of the process likely to be critical in scale-up should be identified in Part IIA of the dossier. Where ranges of batch sizes are proposed,it should be shown that variations in batch size would not adversely alter the characteristics of the finished product.It is envisaged that those parameters listed in the Validation scheme(Annex I)will need to be re-validated once further scale-up is proposed post-authorisation.6.CHANGE CONTROLClearly defined procedures are needed to control changes proposed in production processes. Such procedures should tightly control planned changes,ensure that sufficient supporting data are generated to demonstrate that the revised process will result in a product of the desired quality,consistent with the approved specification and ensure that all aspects are thoroughly documented and approved.Such procedures are fundamentally part of GMP but may result in the need for variation in the marketing authorisation dossier requiring regulatory authority approval before implementation.Minor changes in SOP’s,equipment,environment etc.which can be shown not to have an impact on the quality of the final product are unlikely to need regulatory approval. However,significant changes to processes(e.g.mixing times,drying temperatures),new equipment involving different design and operating parameters,which are likely to impact on product quality are likely to need prior regulatory authority approval,and the appropriate supporting data should be submitted by way of a variation to the marketing authorisation.In general terms very detailed description of processing instructions and equipment design need not be included in the dossier,otherwise prior approval by variation will be necessary before they can be altered.The strategy proposed in Section4.4above should be followed in order to support such changes and the applicant should conduct full scale validation studies or provide pilot scale data together with the validation scheme outlined in Annex I,depending upon the nature of the product and process,in order to obtain regulatory approval.Refer to guidance on Type I and Type II variations and regulations541/95/EC and542/95/EC as amended for further details.ANNEX IPROCESS VALIDATION SCHEMEWhere validation data on production scale batches are not provided with the application,the validation scheme described below should be submitted by the applicant.This should outline the formal process validation studies to be conducted on production scale batches(usually3 consecutive batches).The information from these studies will be available for verification post authorisation by the supervisory authority according to national procedure.The scheme should be submitted in the marketing authorisation dossier and should include the following information as a minimum:•Short description of the process with a summary of the critical processing steps or critical parameters to be monitored during validation•Finished Product Specification(release)•Details of Analytical Methods(References to the dossier)•In Process Controls proposed with Acceptance Criteria•Additional testing intended to be carried out(e.g.with proposed acceptance criteria and analytical validation as appropriate)•Sampling plan-where,when and how the samples are taken•Details of methods for recording and evaluation of results•Proposed TimeframeFollowing completion of the scheme,a report containing the following information and signed by the appropriate authorised person should be generated for examination by the supervisory authority according to national procedure:•Batch Analytical Data•Certificates of Analysis•Batch Production Records•Report on unusual findings,modifications or changes found necessary with appropriate rationale•ConclusionsWhere the results obtained show significant deviations from those expected,the regulatory authorities need to be informed immediately.In such cases corrective actions should be proposed and any changes proposed in the manufacturing process should receive prior regulatory approval by way of variation.。
欧盟GMP附录1计算机系统中英文对照
.EUROPEAN COMMISSION欧盟委员会HEALTH AND CONSUMERS DIRECTORATE-GENERAL卫生与消费者协会Public Health and Risk Assessment公共卫生与风险评估Pharmaceuticals药品Brussels,SANCO/C8/AM/sl/ares(2010)1064599EudraLexThe Rules Governing Medicinal Products in the European Union 欧盟药品生产规范Volume 4卷4Good Manufacturing PracticeMedicinal Products for Human and Veterinary Use人用与兽用药品良好生产管理规范Annex 11: Computerised Systems附件11：计算机系统Legal basis for publishing the detailed guidelines: Article 47 of Directive2001/83/EC on the Community code relating to medicinal products for human use and Article 51 of Directive 2001/82/EC on the Community code relating to veterinary medicinal products. This document provides guidance for the interpretation of the principles and guidelines of good manufacturing practice (GMP) for medicinal products as laid down in Directive 2003/94/EC for medicinal products for human use and Directive 91/412/EEC for veterinary use.依法发布的具体指导方针：2001/83/EC第47条人用药品规范和2001/82/EC第51条兽用药品规范。
检验报告常用术语中英文对照
序号 English Chinese 序号 English Chinese 1bend 弯曲 102shrink mark 收缩纹2broken 破烂 103stress mark顶白印3broken label标贴烂 104thin spray喷油过薄4broken screw缧丝断 105uneven coation涂色不圴5burn mark烧痕 106uneven spray喷油不均匀6burr 毛边 107uneven surface高低落差过大 7carton broken外箱烂108untrimmed thread线头过长8color deviatiion色差过大 109water mark水渍9damage 损坏 110wrinkle 皱纹10deform 变形 111wrong assortment错混装11foreign tape纸屑 112wrong color错颜色12dent mark凹陷 113wrong labelling错标贴13dirt mark污渍 114wrong packing错包装14flash 披锋 115wrong products错货品15flow mark胶料注塑纹 116wrong sewing label错缝合标贴16foreign material外物(就是脏东西 117foreign stuffing线头17gate mark水口修不好 118missing letter缺字18glue mark胶水渍 119missing segment缺字划19hole misalignment孔位不正 120part detach配件甩掉20illegible letter字型模糊不清 121part loose配件松21label peel off标贴脱落 122screw not tight缧丝未收紧22label peel up标贴浮起/分离 123uneven table surface台面不平23large gap间隙过大 124wrong letter错字24missing glue漏胶水 125wrong parts错配件25missing label漏标贴 126bent insert纸卡变形26mould 发霉 127air leakage漏气27no glue无胶水 128cannot assembly组装不成功28oil mark油渍 129dim light灯光过暗29oxidization 氧化 130distortion 失真30paint mark补油不良 131intermittent function间断没功能31paint mark喷油渍 132missing parts漏配件32poor coating露底色 133missing products漏货品33poor fitting接合不良 134narrow goal socket袋口过窄34poor glue黏合不良 135no light无灯光35poor hot stamp烫金不良 136no sound无声音36poor parting line接合边位修不好 137noise 噪声37poor printing印刷不良 138non function无功能38poor seal封合位不良 139poor packing包装不良39poor sewing缝合不良 140poor soldering焊接不良40poor silk screen printing丝印不良 141water leakage漏水41poor spray喷油不良 142weak soung声音过弱42poor stitching缝合孔位过大 143wire damage电线烂43poor tampo printing移印不良 144wire exposed电线外露44poor trimmimg修剪不良 145wrong function错功能45poor trimmimg胶边位修不好 146wrong soung错声音46base 底座 147cracking 裂纹47rough edge边位粗糙 148blood mark血渍48rough surface表面粗糙 149high pole test failure电气高压测试失败49rust mark生锈 150insect 昆虫50scratch mark花痕 151sharp edge利边 , 毛刺51screw slip缧丝滑牙 152sharp point尖点52instruction sheet came off缺少说明书 153sharp point利角53hard to assembly装配困难 154short circuit漏电 / 短路 54poor function功能不良 155damaged window sheet彩盒损坏55too loose太松 156label misalinged标贴贴倒56scratch mark刮花 157dislocated 移位57color deviation颜色有差别,色差 158poor label sticking贴纸不良58electro-plating yellownish电镀变黄 159poor molding注塑不良59electro-plating peel off电镀脱落 160poor packing包装不良60electro-plating abrase电镀擦花 161poor electro-plating电镀不良61tempo incomplete移印不完整 162missing Part缺少附件62tempo off position移印移位 163oversize 尺寸过大63paint abrase喷油擦花 164packing damaged包装损坏64electro-plating rainbow电镀彩虹印 165poor bewing车缝不良65electro-plating shadow电镀阴阳色 166poor soldering焊接不良66electro-plating black mark电镀发黑 167poor shrink wrap收缩包装不良 67oxidatton 氧化 168poor tampo移印不良68inner carton内盒 169seam open车缝开口69gift box彩盒 170seam torn车缝穿洞70ejector mark顶针位 171stripping screw螺丝打滑71flow mark流水痕 172wrong instruction sheet 说明书错误Defect name72flow line流水纹 173blister 吸塑73fold mark折痕 174FOLD MARK ON GIFT彩盒折痕74white mark发白 175GIFT BOX DEFORM彩盒压变形 75poor transparency 透明度不良 176BLISTER DEFORM吸塑变形76sink mark凹痕 177BLISTER CRACK吸塑裂77poor contact接触不良 178BLISTER POOR HEAT SEALING吸塑不良78loosen 脱落 179gift box unseal彩盒无封口贴 79air-bubble on painting漆上有气泡 180poor silk sckeen prining印刷不良 80painting scratched油漆刮花 181over plating电镀过多 81painting peeled off油漆脱落 182under plating电镀不足82pough surface painting油漆面粗糙 183color mismatch颜色不配对83rivet 铆钉 184color misalignment颜色不配对 84blister 泡盒185color deviation颜色有差别,色差 85rust mark锈迹 186electro-plating yellownish电镀变黄86flow mark流水痕 187electro-plating peel off电镀脱落87flow line流水纹 188electro-plating abrase电镀擦花88fold mark折痕 189tempo incomplete移印不完整 89white mark发白190tempo off position移印移位90poor transparency透明度不良 191paint abrase喷油擦花91sink mark凹痕 192electro-plating rainbow电镀彩虹印 92poor contact 接触不良 193electro-plating shadow电镀阴阳色 93loosen 脱落 194electro-plating black mark电镀发黑94air-bubble on painting漆上有气泡 195oxidatton 氧化95painting scratched油漆刮花 196inner carton内盒96painting peeled off油漆脱落 197gift box彩盒97pough surface painting油漆面粗糙 198ejector mark顶针位98rivet 铆钉 199rust mark锈迹99blister 泡盒 200fixed sleeve 固定套100spring 弹簧 201Cover Plate面板101Lining 内衬 202Slide tube伸缩管203Stem Extension延长杆。
欧盟GMP附录15：确认与验证（修订版英文中文）
EUROPEAN COMMISSIONENTERPRISE DIRECTORATE-GENERALSingle market, regulatory environment, industries under vertical legislationPharmaceuticals and cosmeticsBrussels,30 March 2015EudraLex欧盟药品管理法Volume 4EU Guidelines forGood Manufacturing Practice forMedicinal Products for Human and Veterinary Use 第四卷欧盟人用和兽用药品GMP指南Annex 15: Qualification and Validation附录15:确认和验证Legal basis for publishing the detailed guidelines:Article 47 of Directive 2001/83/EC on the Community code relating to medicinal products for human use and Article 51 of Directive 2001/82/EC on the Community code relating to veterinary medicinal products. This document provides guidance for the interpretation of the principles and guidelines of good manufacturing practice (GMP) for medicinal products as laid down in Directive 2003/94/EC for medicinal products for human use and Directive 91/412/EEC for veterinary use.发布该细化指南的法律依据:人用药物欧共体法案指令2001/83/EC第47章和兽用药物欧共体法案指令2001/82/EC第51章。
欧盟GMP附录1(征求意见稿)无菌药品-中英文对照
Annex 1 Manufacture of Sterile Medicinal Products 附录1 无菌药品的生产Document map文件结构图Section Number 章节号General overview 总览1. Scope 1.范围Additional areas (other than sterile medicinal products) where the general principles of the annex can be applied.可适用附录总则的额外区域（无菌药品除外）2. Principle 2.原则General principles as applied to the manufacture of medicinal products. 适用于药品生产的总体原则。
3. Pharmaceutical Quality System (PQS) 3.制药质量体系（PQS）Highlights the specific requirements of the PQS when applied to sterile medicinal products.强调应用于无菌药品时，PQS的具体要求。
4. Personnel 4.人员Guidance on the requirements for specific training, knowledge and skills. Also gives guidance to the qualification of personnel.有关具体培训、知识和技能要求的指南。
也提供人员确认指南。
5. Premises 5.厂房General guidance regarding the specific needs for premises design and also guidance on the qualification of premises including the use of barrier technology.有关厂房设计的具体需求的总体指南，以及有关厂房确认（包括屏障技术的使用）的指南。
欧盟GMP
欧盟GMP(EUGMP)欧洲药品生产和质量管理规范附录15验证和确认EU GMP ANNEX 15 Qualification and validation (July 2001) ACUANNEX 15 附件15Qualification and Validation确认和验证Table of Contents 目录1. Qualification and Validation 确认和验证2. Planning for Validation 验证计划3. Documentation 文件4. Qualification 确认5. Processs Validation. 工艺验证6. Cleaning Validation 清洁验证7. Change Control 变更控制8. Revalidation 再验证9. Glossary 术语表Principle 原理This Annex describes the principles of qualification and validation which are applicable to the manufacture of medicinal products. It is a requirement of GMP that manufacturers identify what validation work is needed to prove control of the critical aspects of their particular operations. Significant changes to the facilities, the equipment and the processes, which may affect the quality of the product, should be validated. A risk assessment approach should be used to determine the scope and extent of validation.本附件描述了确认和验证的原理，适用于医药产品的生产者。
检验报告常用术语中英文对照
序号 English Chinese 序号 English Chinese 1bend 弯曲 102shrink mark收缩纹2broken 破烂 103stress mark顶白印3broken label标贴烂 104thin spray喷油过薄4broken screw缧丝断 105uneven coation涂色不圴5burn mark烧痕 106uneven spray喷油不均匀6burr 毛边 107uneven surface高低落差过大 7carton broken外箱烂108untrimmed thread线头过长8color deviatiion色差过大 109water mark水渍9damage 损坏 110wrinkle 皱纹10deform 变形 111wrong assortment错混装11foreign tape纸屑 112wrong color错颜色12dent mark凹陷 113wrong labelling错标贴13dirt mark污渍 114wrong packing错包装14flash 披锋 115wrong products错货品15flow mark胶料注塑纹 116wrong sewing label错缝合标贴16foreign material外物(就是脏东西 117foreign stuffing线头17gate mark水口修不好 118missing letter缺字18glue mark胶水渍 119missing segment缺字划19hole misalignment孔位不正 120part detach配件甩掉20illegible letter字型模糊不清 121part loose配件松21label peel off标贴脱落 122screw not tight缧丝未收紧22label peel up标贴浮起/分离 123uneven table surface台面不平23large gap间隙过大 124wrong letter错字24missing glue漏胶水 125wrong parts错配件25missing label漏标贴 126bent insert纸卡变形26mould 发霉 127air leakage漏气27no glue无胶水 128cannot assembly组装不成功28oil mark油渍 129dim light灯光过暗29oxidization 氧化 130distortion 失真30paint mark补油不良 131intermittent function间断没功能31paint mark喷油渍 132missing parts漏配件32poor coating露底色 133missing products漏货品33poor fitting接合不良 134narrow goal socket袋口过窄34poor glue黏合不良 135no light无灯光35poor hot stamp烫金不良 136no sound无声音36poor parting line接合边位修不好 137noise 噪声37poor printing印刷不良 138non function无功能38poor seal封合位不良 139poor packing包装不良39poor sewing缝合不良 140poor soldering焊接不良40poor silk screen printing丝印不良 141water leakage漏水41poor spray喷油不良 142weak soung声音过弱42poor stitching缝合孔位过大 143wire damage电线烂43poor tampo printing移印不良 144wire exposed电线外露44poor trimmimg修剪不良 145wrong function错功能45poor trimmimg胶边位修不好 146wrong soung错声音46base 底座 147cracking 裂纹47rough edge边位粗糙 148blood mark血渍48rough surface表面粗糙 149high pole test failure电气高压测试失败 49rust mark 生锈 150insect 昆虫50scratch mark花痕 151sharp edge利边 , 毛刺51screw slip缧丝滑牙 152sharp point尖点52instruction sheet came off缺少说明书 153sharp point利角53hard to assembly装配困难 154short circuit漏电 / 短路 54poor function功能不良 155damaged window sheet彩盒损坏55too loose太松 156label misalinged标贴贴倒56scratch mark刮花 157dislocated 移位57color deviation颜色有差别,色差 158poor label sticking贴纸不良58electro-plating yellownish电镀变黄 159poor molding注塑不良59electro-plating peel off电镀脱落 160poor packing包装不良60electro-plating abrase电镀擦花 161poor electro-plating电镀不良61tempo incomplete移印不完整 162missing Part缺少附件62tempo off position移印移位 163oversize 尺寸过大63paint abrase喷油擦花 164packing damaged包装损坏64electro-plating rainbow电镀彩虹印 165poor bewing车缝不良65electro-plating shadow电镀阴阳色 166poor soldering焊接不良66electro-plating black mark电镀发黑 167poor shrink wrap收缩包装不良67oxidatton 氧化 168poor tampo移印不良68inner carton内盒 169seam open车缝开口69gift box彩盒 170seam torn车缝穿洞70ejector mark顶针位 171stripping screw螺丝打滑71flow mark流水痕 172wrong instruction sheet 说明书错误Defect name72flow line流水纹 173blister 吸塑73fold mark折痕 174FOLD MARK ON GIFT彩盒折痕74white mark发白 175GIFT BOX DEFORM彩盒压变形 75poor transparency透明度不良 176BLISTER DEFORM吸塑变形76sink mark凹痕 177BLISTER CRACK吸塑裂77poor contact接触不良 178BLISTER POOR HEAT SEALING吸塑不良78loosen 脱落 179gift box unseal彩盒无封口贴 79air-bubble on painting漆上有气泡180poor silk sckeen prining印刷不良 80painting scratched油漆刮花 181over plating电镀过多 81painting peeled off油漆脱落 182under plating电镀不足82pough surface painting油漆面粗糙 183color mismatch颜色不配对83rivet 铆钉 184color misalignment颜色不配对 84blister 泡盒 185color deviation 颜色有差别,色差 85rust mark锈迹 186electro-plating yellownish电镀变黄86flow mark流水痕 187electro-plating peel off电镀脱落87flow line流水纹 188electro-plating abrase电镀擦花88fold mark折痕 189tempo incomplete移印不完整 89white mark发白 190tempo off position移印移位90poor transparency透明度不良 191paint abrase喷油擦花91sink mark凹痕 192electro-plating rainbow电镀彩虹印 92poor contact接触不良193electro-plating shadow电镀阴阳色 93loosen 脱落 194electro-plating black mark电镀发黑94air-bubble on painting漆上有气泡 195oxidatton 氧化95painting scratched油漆刮花 196inner carton内盒96painting peeled off油漆脱落 197gift box彩盒97pough surface painting油漆面粗糙 198ejector mark顶针位98rivet 铆钉 199rust mark锈迹99blister 泡盒 200fixed sleeve 固定套100spring 弹簧 201Cover Plate面板101Lining 内衬 202Slide tube伸缩管203Stem Extension延长杆。
- 1、下载文档前请自行甄别文档内容的完整性，平台不提供额外的编辑、内容补充、找答案等附加服务。
- 2、"仅部分预览"的文档,不可在线预览部分如存在完整性等问题,可反馈申请退款(可完整预览的文档不适用该条件!)。
- 3、如文档侵犯您的权益，请联系客服反馈,我们会尽快为您处理(人工客服工作时间：9:00-18:30)。
INDEX
FORMAT Process validation Summary report cover sheet.工艺验证总结报告封面页 Validation Report Approval验证报告批准 Index引言 Introduction简介 References参考 Batch References批参考 Validation of Dry mixing and Granulation干混和制粒确证 Validation of Drying Process干燥过程确证 Validation of Blending Process混合过程确证 Validation of Lubrication Process润滑过程确证 Validation of Compression Process压缩过程确证 Worst case study of Tablet Hardness硬度最差情况研究 Impact study of power failure in compression process压片过程电力故障影响研究 Comparison of in process results with quality control results质量控制的过程比较结 果End of compression results as per Finished Product Specification压片结束结果 Reject classification不合格分类 Validation final conclusion确证最后结论
4.0 VALIDATION OF DRYMIXING AND GRANULATION PROCESS: 干混、制粒工序验证 The validation was done as per point no. 12.3 of Validation Protocol.
The sifted Paracetamol BP/Ph.Eur, Pregelatinised maize starch BP/Ph.Eur (Pregelatinised Starch) and Maize Starch BP/Ph.Eur are loaded into RMG and Dry mixing is carried out for 10,15 and 20 minutes at slow speed. Samples were withdrawn from 5 different positions of RMG and analyzed for assay of Paracetamol.
Sample Location样 品位置
Top 顶部
Middle Left 中左
Middle 中部
Assay in mg
495.1
501.3
496.7
99.4
Middle Right 中右
499.6
100.4
Bottom 底部
497.9
99.9
0.52 %
A.R.NO.:BPV90070
Mean 平均
Batch No批号. 907001 (Lot - I) (10 Minutes)
Sample Location
样品位置
Top 顶部
Middle Left 中左
Middle 中部
Middle Right 中右
Bottom 底部
A.R.NO.: BPV 90066
Mean 平均
RSD %
Assay in mg
Sampling was carried out as per point No. 15.0 and 16.0 (a) of the validation protocol. 按照验证方案12.3进行确证。 过筛后的对乙酰氨基酚，预胶化玉米淀粉和玉米淀粉加载到RMG中，低速干混10,15和20分钟。
Page 6 of 35 Doc No.:PVSR: B08005 / 0.5M / 00 Ref.Protocol No.:PVP: B08005 / 0.5M / 00
批号Batch No. 907001 (Lot - I) (15 Minutes15分钟)
Sample Location样 品位置
Product
BAFNA PHARMACEUTICALS LIMITED
Page 1 of 35
PROCESS VALIDATION SUMMARY REPORT Doc No.:PVSR: B08005 / 0.5M / 00
Paracetamol tablets 500 mg
Ref.Protocol No.:PVP: B08005 / 0.5M / 00
Doc. No. MFR: B08005 / 0.5 M / 00
2 Batch Manufacturing Record 批生产记录
Doc. No. BMR: B08005 / 0.5 M / 00
3 Finished Product Specification 成品规格
Doc. No. FPS: F08005.
3.0
BATCH REFERENCE批参考
Paracetamol tablets 500 mg Paracetamol tablets 500 mg Paracetamol tablets 500 mg
Batch No批号.: 907001 Mfg. Date生产日期: July. 2009 Exp. Date有效日期: June. 2012 Batch size批量: 5,00,000 Tablets
Paracetamol tablets 500 mg
Байду номын сангаас
Page 4 of 35 Doc No.:PVSR: B08005 / 0.5M / 00 Ref.Protocol No.:PVP: B08005 / 0.5M / 00
1.0
INTRODUCTION简介
This report summarizes the results of process validation performed for Batch No. 907001, 907002, and 907003 of Batch size 0.5 M tablets as per Process Validation Protocol No. PVP: B08005 / 0.5M / 00.
493.3
497.5
496.0
497.8
496.1
496.1
0.36 %
Assay in %
98.7
99.5
99.2
Batch No. 907001 (Lot - II) (10 Minutes)
Sample Location样 品位置
Top 顶部
Middle Left 中左
Middle 中部
Assay in mg
Product
BAFNA PHARMACEUTICALS LIMTED PROCESS VALIDATION SUMMARY REPORT
Paracetamol tablets 500 mg
Page 5 of 35 Doc No.:PVSR: B08005 / 0.5M / 00 Ref.Protocol No.:PVP: B08005 / 0.5M / 00
报告总结验证数据的批号为907001, 907002, 907003和批量50万片
2.0
REFERENCES参考文献
The batch was manufactured and analysed as per following documents.批生产和检验相关文件
1 Master Formula Record 主要处方记录
Batch No. 批号: 907002 Mfg. Date生产日期: July. 2009 Exp. Date有效日期: June. 2012 Batch size批量: 5,00,000 Tablets
Batch No批号.: 907003 Mfg. Date生产日期: July. 2009 Exp. Date有效日期: June. 2012 Batch size批量: 5,00,000 Tablets
BAFNA PHARMACEUTICALS LIMTED PROCESS VALIDATION SUMMARY REPORT
Paracetamol tablets 500 mg
Page 3 of 35 Doc No.:PVSR: B08005 / 0.5M / 00 Ref.Protocol No.:PVP: B08005 / 0.5M / 00
PROCESS VALIDATION SUMMARY REPORT 工艺验证总结报告
FOR MANUFACTURING PROCESS OF
Paracetamol tablets 500 mg 对乙酰氨基酚500mg片生产工艺
Product
BAFNA PHARMACEUTICALS LIMTED PROCESS VALIDATION SUMMARY REPORT
门
Quality Assurance QA
Signature签 字
Manager经理 Production生 产
Reviewed By 审
核
Reviewed By 审
核
RAVI CHANDRAN.N.R JAYANTHA.T
Reviewed By 审
核
RAGHAVENDRAN.V
Approved By 批
Paracetamol tablets 500 mg
Page 2 of 35 Doc No.:PVSR: B08005 / 0.5M / 00 Ref.Protocol No.:PVP: B08005 / 0.5M / 00