Specification and Validation of New Control Algorithms for Electric Drives using SpecC Lang
国际药物注册英语词汇
国际药物注册英语词汇互译FDA（food and drug administration）：（美国）食品药品监督管理局NDA（new drug application）：新药申请ANDA（abbreviated new drug application）：简化新药申请EP（export application）：出口药申请（申请出口不被批准在美国销售的药品）treatment IND：研究中的新药用于治疗abbreviated（new）drug：简化申请的新药DMF（drug master file）：药物主文件（持有者为谨慎起见而准备的保密资料，可以包括一个或多个人用药物在制备、加工、包装和贮存过程中所涉及的设备、生产过程或物品。
只有在DMF持有者或授权代表以授权书的形式授权给FDA，FDA在审查IND、NDA、ANDA时才能参考其内容）holder：DMF持有者CFR（code of federal regulation）：（美国）联邦法规PANEL：专家小组batch production：批量生产；分批生产batch production records：生产批号记录post or pre-market surveillance：销售前或销售后监督informed consent：知情同意（患者对治疗或受试者对医疗试验了解后表示同意接受治疗或试验）prescription drug：处方药OTC drug（over—the—counter drug）：非处方药U.S. public health service：美国卫生福利部NIH（national institute of health）：（美国）全国卫生研究所animal trail：动物试验accelerated approval：加速批准standard drug：标准药物investigator ：研究人员；调研人员preparing and submitting：起草和申报submission：申报；递交benefit(s)：受益risk（s）：受害drug product：药物产品drug substance：原料药established name：确定的名称generic name：非专利名称proprietary name：专有名称；INN（international nonproprietary name）：国际非专有名称narrative summary: 记叙体概要adverse effect：副作用adverse reaction：不良反应protocol：方案archival copy：存档用副本review copy：审查用副本official compendium：法定药典（主要指USP、NF）．USP（the united state pharmacopeia）：美国药典（现已和NF合并一起出版）NF（national formulary）：（美国）国家药品集official＝pharmacopeial = compendial：药典的；法定的；官方的agency：审理部门（指FDA）sponsor：主办者（指负责并着手临床研究者）identity：真伪；鉴别；特性strength：规格；规格含量（每一剂量单位所含有效成分的量）labeled amount：标示量regulatory specification：质量管理规格标准（NDA提供）regulatory methodology：质量管理方法（FDA用于考核原料药或药物产品是否符合批准了的质量管理规格标准的整套步骤）regulatory methods validation：管理用分析方法的验证（FDA对NDA提供的方法进行验证）Dietary supplement：食用补充品ICH（International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use)人用药物注册技术要求国际协调会议ICH：Quality-质量Q1A(R2): Stability Testing of New Drug Substances and Products (SecondRevision)新原料药和制剂的稳定性试验（第二版）Q1B: Photostability Testing of New Drug Substances and Products新原料药和制剂的光稳定性试验Q1C: Stability Testing for New Dosage Forms新制剂的稳定性试验Q1D: Bracketing and Matrixing Designs for Stability Testing of Drug Substances and Drug Products原料药和制剂稳定性试验的交叉和矩阵设计Q1E: Evaluation of Stability Data对稳定性数据的评估处理Q1F: Stability Data Package for Registration Applications in Climatic Zones III and IV在气候带III和IV，药物注册申请所提供的稳定性数据Q2A: Text on Validation of Analytical Procedures分析程序的验证Q2B: Validation of Analytical Procedures: Methodology分析程序的验证：方法学Q3A(R): Impurities in New Drug Substances (Revised Guideline)新原料药中的杂质（修订版）Q3B(R): Impurities in New Drug Products (Revised Guideline)新制剂中的杂质（修订版）Q3C: Impurities: Guideline for Residual Solvents杂质：残留溶剂指南Q3C(M): Impurities: Guideline for Residual Solvents (Maintenance)杂质：残留溶剂指南（修改内容）Q4: Pharmacopoeias药典Q4A: Pharmacopoeial Harmonisation 药典的协调Q4B: Regulatory Acceptance of Pharmacopoeial Interchangeability药典互替在法规上的可接受性Q5A: Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin来源于人或者动物细胞系的生物技术产品的病毒安全性评估Q5B: Quality of Biotechnological Products: Analysis of the ExpressionConstruct in Cells Used for Production of r-DNA Derived Protein Products生物技术产品的质量：源于重组DNA的蛋白质产品的生产中所用的细胞中的表达构建分析Q5C: Quality of Biotechnological Products: Stability Testing ofBiotechnological/Biological Products生物技术产品的质量：生物技术/生物产品的稳定性试验Q5D: Derivation and Characterisation of Cell Substrates Used forProduction of Biotechnological/Biological Products用于生产生物技术/生物产品的细胞底物的起源和特征描述Q5E: Comparability of Biotechnological/Biological Products Subject toChanges in Their Manufacturing Process基于不同生产工艺的生物技术产品/生物产品的可比较性Q6: Specifications for New Drug Substances and Products新原料药和制剂的质量规格Q6A: Specifications: Test Procedures and Acceptance Criteria for New DrugSubstances and New Drug Products: Chemical Substances质量规格：新原料药和新制剂的检验程序和可接收标准：化学物质Q6B: Specifications: Test Procedures and Acceptance Criteria forBiotechnological/Biological Products质量规格：生物技术/生物产品的检验程序和可接收标准Q7: Good Manufacturing Practices for Pharmaceutical Ingredients活性药物成份的GMPQ7A: Good Manufacturing Practice Guide for Active PharmaceuticalIngredients活性药物成份的GMP指南Q8: Pharmaceutical Development药物研发Q9: Quality Risk Management质量风险管理ICH：Safety-安全S1A: Guideline on the Need for Carcinogenicity Studies of Pharmaceuticals药物致癌性研究需要的指南S1B: Testing for Carcinogenicity of Pharmaceuticals药物致癌性的检验S1C: Dose Selection for Carcinogenicity Studies of Pharmaceuticals药物致癌性研究之剂量选择S1C(R): Addendum: Addition of a Limit Dose and Related Notes附录：极限剂量和有关注释的的补充S2A: Guidance on Specific Aspects of Regulatory Genotoxicity Tests forPharmaceuticals受法规管辖的药物基因毒性检验的特定方面的指南S2B: Genotoxicity: A Standard Battery for Genotoxicity Testing forPharmaceuticals基因毒性：药物基因毒性检验的标准S3A: Note for Guidance on Toxicokinetics: The Assessment of SystemicExposure in Toxicity Studies毒物代谢动力学指南的注释：毒性研究中的全身性暴露量的评估S3B: Pharmacokinetics: Guidance for Repeated Dose Tissue DistributionStudies药物代谢动力学：重复剂量的组织分布研究指南S4: Single Dose Toxicity Tests单剂量毒性检验S4A: Duration of Chronic Toxicity Testing in Animals (Rodent andNon-Rodent Toxicity Testing)动物体内慢性毒性持续时间的检验（啮齿动物和非啮齿动物毒性检验）S5A: Detection of Toxicity to Reproduction for Medicinal Products药物对生殖发育的毒性的检验S5B(M): Maintenance of the ICH Guideline on Toxicity to Male Fertility:An Addendum to the Guideline on Detection of Toxicity to Reproduction forMedicinal Products对男性生殖能力的毒性的指南的变动：药物对生殖发育的毒性的检验指南增加了一个附录S6: Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals生物技术生产的药物的临床前安全评价S7A: Safety Pharmacology Studies for Human Pharmaceuticals人用药的安全药理学研究S7B: The Nonclinical Evaluation of the Potential for Delayed VentricularRepolarization(QT Interval Prolongation) By Human Pharmaceuticals药物延迟心室复极化（QT间期）潜在作用的非临床评价S8: Immunotoxicology Studies for Human Pharmaceuticals人用药免疫毒理学研究M3(M): Maintenance of the ICH Guideline on Non-Clinical Safety Studies for the Conduct of Human Clinical Trials for Pharmaceuticals药物的对人临床试验的非临床安全研究指南的变动E-Efficacy（有效）E1: The Extent of Population Exposure to Assess Clinical Safety for DrugsIntended for Long-Term Treatment of Non-Life-Threatening Conditions对用于无生命危险情况下长期治疗的药物进行临床安全评估的族群暴露量范围E2A: Clinical Safety Data Management: Definitions and Standards forExpedited Reporting临床安全数据管理：速报制度的定义和标准E2B(R): Revision of the E2B(M) ICH Guideline on Clinical Safety DataManagement Data Elements for Transmission of Individual Case Safety Reports个案安全报告送交的临床安全数据管理的数据要素指南（E2B（M））的修订版E2B (M): Maintenance of the Clinical Safety Data Management including:Data Elements for Transmission of Individual Case Safety Reports临床安全数据管理的变动包括：个案安全报告送交的数据要素E2B(M): Maintenance of the Clinical Safety Data Management includingQuestions and Answers临床安全数据管理的变动，包括问答E2C: Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs临床安全数据管理：已上市药品的周期性安全数据更新报告Addendum to E2C: Periodic Safety Update Reports for Marketed DrugsE2C的附录：已上市药品的周期性安全数据更新报告E2D: Post-Approval Safety Data Management: Definitions and Standards for Expedited Reporting批准后的安全数据管理：速报制度的定义和标准E2E: Pharmacovigilance Planning药物警戒计划E3: Structure and Content of Clinical Study Reports临床研究报告的结构和内容E4: Dose-Response Information to Support Drug Registration支持药品注册的剂量－效应资料E5: Ethnic Factors in the Acceptability of Foreign Clinical Data引入海外临床数据时要考虑的人种因素E6: Good Clinical Practice: Consolidated GuidelineGCP：良好的临床规范：统一的指南E7: Studies in Support of Special Populations: Geriatrics对特定族群的支持的研究：老人病学E8: General Considerations for Clinical Trials对临床试验的总的考虑E9: Statistical Principles for Clinical Trials临床试验的统计原则E10: Choice of Control Group and Related Issues in Clinical Trials临床试验中控制组和有关课题的选择E11: Clinical Investigation of Medicinal Products in the Pediatric Population小儿科药物的临床调查E12A: Principles for Clinical Evaluation of New Antihypertensive Drugs新抗高血压药物的临床评价原则E14: The Clinical Evaluation of QT/QTc Interval Prolongation andProarrhythmic Potential for Non-Antiarrhythmic Drugs非抗心率失常药物的QT/QTc 间期和致心率失常潜在作用的临床评价Multidisciplinary Guidelines 多学科兼容的指南M1: Medical Terminology医学术语M2: Electronic Standards for Transmission of Regulatory Information (ESTRI)药政信息传递之电子标准M3: Timing of Pre-clinical Studies in Relation to Clinical Trials (SeeSafety Topics)有关临床试验的临床前研究的时间安排M4: The Common Technical Document (See CTD section for complete Status ofthe guidelines)通用技术文件（见有关CTD章节）M5: Data Elements and Standards for Drug Dictionaries药物词典的数据要素和标准临床试验常用的英文缩略语TTP：time-to-progression 疾病进展时间SAE：severity Adverse Event 严重不良事件AE：Adverse Event 不良事件SOP：Standard Operating Procedure 标准操作规程CRF：Case Report form 病例报告表DLT：剂量限制毒性MTD：最大耐受剂量KPS：Karnofsky Performance Status行为状态评分CR：complete response完全缓解PR：partial response部分缓解SD：病情稳定PD：progressive disease病情进展CTC：常用药物毒性标准IEC：independent ethics committee 独立伦理委员会IRB ：institutional review board 伦理委员会CRA：临床研究助理CRO：Contract Research Organization 合同研究组织DFS：Disease Free Survival 无病生存期OS：（Overall Survival）总生存时间IC：Informed consent 知情同意ADR：Adverse Drug Reaction 不良反应GAP：Good Agricultural Practice 中药材种植管理规范GCP：Good Clinical Practice 药物临床试验质量管理规范GLP：Good Laboratory Practice 药品实验室管理规范GMP：Good Manufacturing Practice 药品生产质量管理规范GSP：Good Supply Practice 药品经营质量管理规范GUP：Good Use Practice 药品使用质量管理规范PI ：Principal investigator 主要研究者CI：Co-inveatigator 合作研究者SI ：Sub-investigator 助理研究者COI ：Coordinating investigtor 协调研究者国际药物注册英语词汇DGMP：医疗器械生产质量管理规范ICF：Informed consent form 知情同意书RCT ：randomized controlled trial, 随机对照试验NRCCT：non-randomized concurrent controlled trial, 非随机同期对照试验EBM：evidence-based medicine 循证医学RCD：randomized cross-over disgn 随机交叉对照试验HCT：historial control trial, 历史对照研究RECIST：Response Evaluation Criteria In Solid Tumors. 实体瘤疗效反应的评价标准QC：Quality Control质量控制UADR：Unexpected Adverse Drug Reaction，非预期药物不良反应11 / 11。
欧盟GMP附录15：确认与验证(修订版英文+中文)
1.2.Qualification and validation activities should only be performed by suitably trained personnel who follow approved procedures.
iv.Change control and deviation management for qualification and validation;
iv.确认与验证活动的变更控制和偏差管理。
v. Guidance on developing acceptance criteria;
v.开发可接受标准的指南。
1.4.应当在验证主计划（VMP）或其等同文件中，清晰地界定和记录现场确认与验证程序的关键性要素。
1.5. The VMP or equivalent document should define the qualification/validation system and include or reference information on at least the following:
Pharmaceuticals and cosmetics
Brussels,30 March 2015
EudraLex
欧盟药品管理法
Volume 4
EU Guidelines for
Good Manufacturing Practice for
Medicinal Products for Human and 险管理的方法应作为质量风险管理系统的一部分贯穿于药品的整个生命周期，应基于对设施、设备、公用系统和工艺的论证和书面风险评估决定确认和验证的范围和程度。回顾性验证不再被认为是可接受的方式。如果方法经过论证，并且获取数据的整个过程中有足够的保证性控制措施，也可以使用从生产商自身程序以外获得的用于支持确认和/或验证研究的数据。
测试工程师岗位职责描述15篇
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产品验收标准和验收方法英文
产品验收标准和验收方法英文Product Acceptance Standards and Acceptance MethodsProduct Acceptance Standards:1. Functional requirements: The product must meet all the specified functional requirements as defined in the project scope and requirements document.2. Performance criteria: The product must perform to the specified performance criteria, including speed, accuracy, response time, and stability.3. Compatibility: The product must be compatible with the required software and hardware environment as specified in the project scope.4. Usability: The product must be user-friendly and intuitive, allowing users to easily understand and navigate its features.5. Reliability: The product must be reliable and stable, with minimal downtime and maximum uptime.6. Security: The product must adhere to all security standards and protocols, protecting data and preventing unauthorized access.7. Maintainability: The product must be easily maintainable, allowing the implementation of updates, bug fixes, and enhancements in a timely manner.8. Scalability: The product should have the potential to handle increased workload or user demand without experiencing performance degradation.9. Compliance: The product must comply with all applicable industry standards and regulations.Product Acceptance Methods:1. Testing: Conduct comprehensive testing on the product toensure it meets the specified acceptance criteria. This may include functional testing, performance testing, security testing, and user acceptance testing.2. User feedback: Gather feedback from users and stakeholders through surveys, interviews, or focus groups to evaluate the product's usability and meet their requirements.3. Prototype evaluation: Obtain feedback from users and stakeholders during the development process by providing prototype versions of the product for evaluation.4. Documentation review: Review and evaluate the product's documentation, including user manuals, installation guides, and technical specifications, to ensure they are accurate, comprehensive, and user-friendly.5. Onsite observation: Observe the product in a real-world environment to assess its performance, functionality, and usability in actual usage scenarios.6. Peer review: Engage experts or peers to evaluate the product against the defined acceptance standards, ensuring it meets industry best practices and quality standards.7. Vendor support: Collaborate with the product vendor or supplier to verify that the product meets all specified requirements and standards.8. Compliance checks: Conduct audits or inspections to ensure that the product complies with relevant industry regulations and standards.。
USP401226药典的确认中英文对照
1226 VERIFICATION OF COMPENDIAL PROCEDURES 药典方法的确认The intent of this general information chapter is to provide general information on the verification of compendial procedures that are being performed for the first time to yield acceptable results utilizing the personnel, equipment, and reagents available.此章节的意图是对药典方法的确认提供基本资料，使用人员，设备和试剂使第一次进行运用药典方法以产生可接受的结果。
This chapter is not intended for retroactive application to already successfully established laboratory procedures. The chapter Validationof Compendial Procedures <1225>provides general information on characteristics that should be considered for various test categories and on the documentation that should accompany analytical procedures submitted for inclusion in USP–NF. Verification consists of assessing selected analytical performance characteristics, such as those that are described in chapter<1225>to generate appropriate, relevant datarather than repeating the validation process.此章节并不旨在对已经成功建立的实验室方法进行回顾性运用。
GMP常用英语单词
Abbreviated New drug简化申请的新药Accelerated approval加速批准Adverse effcet副作用Adverse reaction不良反应Agency审理部门ANDA(Abbreviated New drug application)简化新药申请Animal trial动物试验Archival copy存档用副本Batch production records生产批号记录Batch production批量生产CFR （Code of federal regulation ）(美)联邦法规Clinical trial临床试验COS/CEP欧洲药典符合性认证Dietary supplement食品补充品DMF(Drug master file)药物主文件Drug substance原料药Generic name非专利名称ICH(International Conference onHarmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use)人用药物注册技术要求国际协调会议IND(Investigation new drug)临床研究申请（指申报阶段，相对于NDA）；研究中的新药（指新药开发阶段，相对于新药而言，即临床前研究结束）Informed consent知情同意INN(international nonproprietary name)国际非专有名称Investigator研究人员；调研人员Labeled amount标示量NDA(New drug application)新药申请NF(National formulary)(美)国家药品集NIH(National Institute of Health)(美)国家卫生研究所Panel专家小组preparing and Submitting起草和申报Prescription drug处方药Proprietary name专有名称Regulatory methodology质量管理方法Regulatory methods validation管理用分析方法的验证Regulatory specification质量管理规格标准Review copy审查用副本Sponsor主办者（指负责并着手临床研究者）Standard drug标准药物Strength规格；规格含量（每一剂量所含有效成分的量）Submission申报；递交Treatment IND研究中的新药用于治疗生产工艺相关Acceptance criteria可接受标准air driers手烘箱Airlock Room气闸室analytical methods分析方法anhydrous无水API原料药Assay 含量at rest静态batch size批量Blending Batches混批Blending Room总混间calibrating校正case-by-case具体分析centigrate摄氏度Changing Room更衣室Charge-in进料chemical properties化学性质Clarity,completeness,or PH of solutions溶液的澄明度、溶解完全性及PH值cleaning agents清洗媒介cleaning procedures清洁程序Cleaning Tools Room洁具室Coating Mixture Preparing Room配浆间Commercial scale可配伍性Concentrated Solution Room浓配室consistency of the process工艺的稳定性critical process关键步骤dedicated专用的Documentation System文件系统dosage form剂型electronic form电子格式electronicsignatures电子签名Emergency Door安全门established schedule预先计划Excipient辅料exhaust排气fermentation发酵Granulation颗粒HAVC(Heating ventilation and air conditioning)空调净化系统Heavy metal重金属historical date历史数据Hydrochloric acid盐酸in operation动态incoming materials进厂物料in-house testing内控检测installation qualification(IQ)安装确认intermediate中间体intermal audits self-inspection自检laboratory control record实验室控制记录laboratory information managementsystem(LIMS)实验室信息管理系统local authorities当地药政部门Loss on drying干燥失重Meet the requirement符合要求Melting point熔点Melting range熔程microbiological specifications微生物标准microorganisms微生物Milling磨粉Mix-ups混放modified facilities设施变更molecular formula分子式Non-dedicated equipment非专用设备Operational qualification(OQ)运行确认Out-of-specification不合格Packaging包装Particle size粒度Perform a blank determination作一个空白对照Personnel Hygiene人员卫生pilot scale中试规模potable water饮用水premises设施process parameters工艺参数Process validation工艺验证，过程验证product quality reviews产品质量回顾production batch records批生产记录proposed indication适应症purification纯化performance qualification(PQ)性能确认Process flow diagrams(PFDS)工艺流程图product validation产品验证regulatory inspection evaluation药政检查Related substance有关物质release放行Residual solvents残留溶剂retention periods保留期限Retention samples留样retention time保留时间Retrospective validation回顾性验证Revalidation再验证review and approve审核并批准route of administration给药途径Sanitation环境卫生scale-up reports报产报告serious GMP deficiencies严重GMP缺陷Sip sterilization in place在线灭菌sodium hydroxide氢氧化钠Specific rotation比旋度specifications标准stability date稳定性数据stability monitoring program稳定性监控计划status状态sterile APIs无菌原料药sterilization消毒succ essive batches连续批号supplier供应商technical transfer技术转化total microbial counts微生物总数traceable可追踪的turnover packages验证文件集Validation master plan验证总计划Validation report验证报告常用中译英系统system物料平衡reconciliation批batch or lot批号batch number批生产记录batch records文件document标准操作规程standard operating proceddures (SOP)生产工艺规程master formula工艺用水water for processing纯化水purified water注射用水water for injection状态标志status mark/label中间产品intermediate product理论产量theoretical yield物料material待验quarantine起始原料staring material洁净室(区)clean room(zone)待包品bulk product成品finished product灭菌sterilization控制点control point质量监督quality surveillance生产过程控制in-process control退货returned product拒收rejected交叉污染cross contamination放行released质量要求quality requirement可追溯性traceability计量确认metrologial confirmation人员净化室room for cleaning human body物料净化室room for cleaning material悬浮粒子airborne particles洁净度cleanliness净化cleaning传递箱pass box洁净服clean working garment洁净工作台clean bench静态at-rest动态operational粗效过滤器roughing filter中效过滤器medium efficiency filter高效过滤器hepa filter安装确认instalation qualification(IQ)运行确认operational qualification(OQ)性能确认performance qualification(PQ)工艺验证process validation。
NPD 新产品开发控制
8
E.C.M.:Engineering Change Management : ECR/ECN
ECR / ECN in PDM
Customer request
PDM work flow
Reject (if someone disagree)
Prepare Initiator
Check
Section manager of initiator
新產品開發風險
大量複製代表大量材料與金錢投入,若產品有任何重大瑕疵,將會造成產品退貨,輕者損失商 譽賠錢解決,嚴重可能使公司經營發生困難
降低風險提升利潤
經由適當有效流程控制,複製經驗,確保產品開發品質控管機制,以提升量產之品質,減低公司 營運風險;經由經驗分享,減少犯錯機會,降低開發時間,使產品快速上市,以取得最佳利潤 .
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適用資料
Current Structures
TPD : Technical Product Document
Date : Apr. 2100, 2000
NPI TPD Documentation
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PE/CE
Cosmatic Inspection Spec
PE
Parts Programming Spec
PE
Product Spec
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Gerber File
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Component Placement List
医药行业专业英语词汇
医药行业专业英语词汇（非常有用）FDA和EDQM术语: CLINICAL?TRIAL：临床试验? ANIMAL?TRIAL：动物试验? ACCELERATED?APPROVAL：加速批准? STANDARD?DRUG：标准药物? INVESTIGATOR：研究人员；调研人员PREPARING?AND?SUBMITTING：起草和申报? SUBMISSION：申报；递交? BENIFIT （S）：受益? RISK（S）：受害? DRUG?PRODUCT：药物产品? DRUG?SUBSTANCE：原料药? ESTABLISHED?NAME：确定的名称? GENERIC?NAME：非专利名称? PROPRIETARY?NAME：专有名称；? INN（INTERNATIONAL?NONPROPRIETARY?NAME）：国际非专有名称? ADVERSE?EFFECT：副作用? ADVERSE?REACTION：不良反应? PROTOCOL：方案? ARCHIVAL?COPY：存档用副本? REVIEW?COPY：审查用副本? OFFICIAL?COMPENDIUM：法定药典（主要指USP、?NF）．? USP （THE?UNITED?STATES?PHARMACOPEIA）：美国药典NF（NATIONAL?FORMULARY）：（美国）国家处方集? OFFICIAL＝PHARMACOPEIAL=?COMPENDIAL：药典的；法定的；官方的? AGENCY：审理部门（指FDA）? IDENTITY：真伪；鉴别；特性? STRENGTH：规格；规格含量（每一剂量单位所含有效成分的量）? LABELED?AMOUNT：标示量? REGULATORY?SPECIFICATION：质量管理规格标准（NDA提供）? REGULATORY?METHODOLOGY：质量管理方法? REGULATORY?METHODS?VALIDATION：管理用分析方法的验证COS/CEP?欧洲药典符合性认证ICH（International?Conference?on?Harmonization?of?Technical?Requirements?for?Registration?of PharmaceuticalsforHumanUse)人用药物注册技术要求国际协调会议ICH文件分为质量、安全性、有效性和综合学科4类。
EU GMP 附录15：确认与验证-英文
PrincipleThis Annex describes the principles of qualification and validation which are applicable tothe facilities, equipment, utilities and processes used for the manufacture of medicinal products and may also be used as supplementary optional guidance for active substances without introduction of additional requirements to EudraLex, Volume 4, Part II. It is a GMP requirement that manufacturers control the critical aspects of their particular operations through qualification and validation over the life cycle of the product and process. Any planned changes to the facilities, equipment, utilities and processes, which may affect the quality of the product, should be formally documented and the impact on the validated status or control strategy assessed. Computerised systemsused for the manufacture of medicinal products should also be validated according to the requirements of Annex 11. The relevant concepts and guidance presented in ICH Q8, Q9, Q10 and Q11 should also be taken into account.GeneralA quality risk management approach should be applied throughout the lifecycle of a medicinal product. As part of a quality risk management system, decisions on the scope and extentof qualification and validation should be based on a justified and documented risk assessment of the facilities, equipment, utilities and processes. Retrospective validation is no longer considered an acceptable approach. Data supporting qualification and/or validation studies which were obtained from sources outside of the manufacturers own programmes may be used provided that this approach has been justified and that there is adequate assurance that controls were in place throughout the acquisition of such data.1. ORGANISING AND PLANNING FOR QUALIFICATION AND VALIDATION (1.1-1.8) 1.1. All qualification and validation activities should be planned and take the life cycle of facilities, equipment, utilities, process and product into consideration.1.2. Qualification and validation activities should only be performed by suitably trained personnel who follow approved procedures.1.3. Qualification/validation personnel should report as defined in the pharmaceutical quality system although this may not necessarily be to a quality management or a quality assurance function. However, there should be appropriate quality oversight over the whole validation life cycle.1.4. The key elements of the site qualification and validation programme should be clearly defined and documented in a validation master plan (VMP) or equivalent document.1.5. The VMP or equivalent document should define the qualification/validation system and include or reference information on at least the following:i. Qualification and Validation policy;ii. The organisational structure including roles and responsibilities for qualification and validation activities;iii. Summary of the facilities, equipment, systems, processes on site and the qualification and validation status;iv. Change control and deviation management for qualification and validation;v. Guidance on developing acceptance criteria;vi. References to existing documents;vii. The qualification and validation strategy, including requalification, where applicable.1.6. For large and complex projects, planning takes on added importance and separate validation plans may enhance clarity1.7. A quality risk management approach should be used for qualification and validation activities. In light of increased knowledge and understanding from any changes during the project phase or during commercial production, the risk assessments should be repeated, as required. The way in which risk assessments are used to support qualification and validation activities should be clearly documented.1.8. Appropriate checks should be incorporated into qualification and validation work to ensure the integrity of all data obtained.2. DOCUMENTATION, INCLUDING VMP (2.1-2.10)2.1. Good documentation practices are important to support knowledge management throughout the product lifecycle.2.2. All documents generated during qualification and validation should be approved and authorised by appropriate personnel as defined in the pharmaceutical quality system.2.3. The inter-relationship between documents in complex validation projects should be clearly defined.2.4. Validation protocols should be prepared which defines the critical systems, attributes and parameters and the associated acceptance criteria.2.5. Qualification documents may be combined together, where appropriate, e.g. installation qualification (IQ) and operational qualification (OQ).2.6. Where validation protocols and other documentation are supplied by a third party providing validation services, appropriate personnel at the manufacturing site should confirm suitability and compliance with internal procedures before approval. Vendor protocols may be supplemented by additional documentation/test protocols before use.2.7. Any significant changes to the approved protocol during execution, e.g. acceptance criteria, operating parameters etc., should be documented as a deviation and be scientifically justified.2.8. Results which fail to meet the pre-defined acceptance criteria should be recorded as a deviation and be fully investigated according to local procedures. Any implications for the validation should be discussed in the report.2.9. The review and conclusions of the validation should be reported and the results obtained summarised against the acceptance criteria. Any subsequent changes to acceptance criteria should be scientifically justified and a final recommendation made as to the outcome of the validation.2.10. A formal release for the next stage in the qualification and validation process should be authorised by the relevant responsible personnel either as part of the validation report approval or as a separate summary document. Conditional approval to proceed to the next qualification stage can be given where certain acceptance criteria or deviations have not been fully addressed and there is a documented assessment that there is no significant impact on the next activity.3. QUALIFICATION STAGES FOR EQUIPMENT, FACILITIES, UTILITIES AND SYSTEMS (3.1-3.14)3.1. Qualification activities should consider all stages from initial development of the user requirements specification through to the end of use of the equipment, facility, utility or system. The main stages and some suggested criteria (although this depends on individual project circumstances and may be different) which could be included in each stage are indicated below:User requirements specification (URS) (3.2)3.2. The specification for equipment, facilities, utilities or systems should be defined ina URS and/or a functional specification. The essential elements of quality need to be built in at this stage and any GMP risks mitigated to an acceptable level. The URS should be a point of reference throughout the validation life cycle.Design qualification (DQ) (3.3)3.3. The next element in the qualification of equipment, facilities, utilities, or systems is DQ where the compliance of the design with GMP should be demonstrated and documented. The requirements of the user requirements specification should be verified during the design qualification.Factory acceptance testing (FAT) /Site acceptance testing (SAT) (3.4-3.7)3.4. Equipment, especially if incorporating novel or complex technology, may be evaluated, if applicable, at the vendor prior to delivery.3.5. Prior to installation, equipment should be confirmed to comply with the URS/ functional specification at the vendor site, if applicable.3.6. Where appropriate and justified, documentation review and some tests could be performed at the FAT or other stages without the need to repeat on site at IQ/OQ if it can be shown that the functionality is not affected by the transport and installation.3.7. FAT may be supplemented by the execution of a SAT following the receipt of equipment at the manufacturing siteInstallation qualification (IQ) (3.8-3.9)3.8. IQ should be performed on equipment, facilities, utilities, or systems.3.9. IQ should include, but is not limited to the following:i. Verification of the correct installation of components, instrumentation, equipment, pipe work and services against the engineering drawings and specifications;ii. Verification of the correct installation against pre-defined criteria;iii. Collection and collation of supplier operating and working instructions and maintenance requirements;iv. Calibration of instrumentation;v. Verification of the materials of construction.Operational qualification (OQ) (3.10-3.12)3.10. OQ normally follows IQ but depending on the complexity of the equipment, it may be performed as a combined Installation/Operation Qualification (IOQ).3.11. OQ should include but is not limited to the following:i. Tests that have been developed from the knowledge of processes, systems and equipment to ensure the system is operating as designed;ii. Tests to confirm upper and lower operating limits, and /or “worst case” conditions.3.12. The completion of a successful OQ should allow the finalisation of standard operating and cleaning procedures, operator training and preventative maintenance requirementsPerformance qualification (PQ) (3.13-3.14)3.13. PQ should normally follow the successful completion of IQ and OQ. However, it may in some cases be appropriate to perform it in conjunction with OQ or Process Validation.3.14. PQ should include, but is not limited to the following:i. Tests, using production materials, qualified substitutes or simulated product proven to have equivalent behaviour under normal operating conditions with worst case batch sizes. The frequency of sampling used to confirm process control should be justified;ii. Tests should cover the operating range of the intended process, unless documented evidence from the development phases confirming the operational ranges is available.4. RE-QUALIFICATION (4.1-4.2)4.1. Equipment, facilities, utilities and systems should be evaluated at an appropriate frequency to confirm that they remain in a state of control.4.2. Where re-qualification is necessary and performed at a specific time period, the period should be justified and the criteria for evaluation defined. Furthermore, the possibility of small changes over time should be assessed.5. PROCESS VALIDATION (5.1-5.32)General (5.1-5.15)5.1. The requirements and principles outlined in this section are applicable to the manufacture of all pharmaceutical dosage forms. They cover the initial validation of new processes, subsequent validation of modified processes, site transfers and ongoing process verification. It is implicit in this annex that a robust product development process is in place to enable successful process validation.5.2. Section 5 should be used in conjunction with the current EMA guideline on Process Validation.5.2.1.The guideline on Process Validation is intended to provide guidance on the information and data to be provided in the regulatory submission only. However GMP requirements for process validation continue throughout the lifecycle of the process5.2.2.This approach should be applied to link product and process development. It will ensure validation of the commercial manufacturing process and maintenance of the process in a state of control during routine commercial production.5.3. Manufacturing processes may be developed using a traditional approach or a continuous verification approach. However, irrespective of the approach used, processes must be shown to be robust and ensure consistent product quality before any product is released to the market. Manufacturing processes using the traditional approach should undergo a prospective validation programme, wherever possible, prior to certification of the product. Retrospective validation is no longer an acceptable approach.5.4. Process validation of new products should cover all intended marketed strengths and sites of manufacture. Bracketing could be justified for new products based on extensive process knowledge from the development stage in conjunction with an appropriate ongoing verification programme.5.5. For process validation of products which are transferred from one site to another or within the same site, the number of validation batches could be reduced by the use of a bracketing approach. However, existing product knowledge, including the content of the previous validation, should be available. Different strengths, batch sizes and pack sizes/container types may also use a bracketing approach, if justified.5.6. For the site transfer of legacy products, the manufacturing process and controls must comply with the marketing authorisation and meet current standards for marketing authorisation for that product type. If necessary, variations to the marketing authorisation should be submitted.5.7. Process validation should establish whether all quality attributes and process parameters, which are considered important for ensuring the validated state and acceptable product quality, can be consistently met by the process. The basis by which process parameters and quality attributes were identified as being critical or non-critical should be clearly documented, taking into account the results of any risk assessment activities.5.8. Normally batches manufactured for process validation should be the same size as the intended commercial scale batches and the use of any other batch sizes should be justified or specified in other sections of EudraLex, Volume 4.5.9. Equipment, facilities, utilities and systems used for process validation should be qualified. Test methods should be validated for their intended use.5.10. For all products irrespective of the approach used, process knowledge from development studies or other sources should be accessible to the manufacturing site, unless otherwise justified, and be the basis for validation activities.5.11. For process validation batches, production, development, or other site transfer personnel may be involved. Batches should only be manufactured by trained personnel in accordance with GMP using approved documentation. It is expected that production personnel are involved in the manufacture of validation batches to facilitate product understanding.5.12. The suppliers of critical starting and packaging materials should be qualified prior to the manufacture of validation batches; otherwise a justification based on the application of quality risk management principles should be documented.5.13. It is especially important that the underlying process knowledge for the design space justification (if used) and for development of any mathematical models (if used) to confirm a process control strategy should be available.5.14. Where validation batches are released to the market, this should be pre-defined. The conditions under which they are produced should fully comply with GMP, with the validation acceptance criteria, with any continuous process verification criteria (if used) and with the marketing authorisation or clinical trial authorisation.5.15. For the process validation of investigational medicinal products (IMP), please refer to Annex 13.Concurrent validation (5.16-5.17)5.16. In exceptional circumstances, where there is a strong benefit-risk ratio for the patient, it may be acceptable not to complete a validation programme before routine production starts and concurrent validation could be used. However, the decision to carry out concurrent validation must be justified, documented in the VMP for visibility and approved by authorised personnel.5.17. Where a concurrent validation approach has been adopted, there should be sufficient data to support a conclusion that any given batch of product is uniform and meets the defined acceptance criteria. The results and conclusion should be formally documented and available to the Qualified Person prior to certification of the batch.Traditional process validation (5.18-5.22)5.18. In the traditional approach, a number of batches of the finished product are manufactured under routine conditions to confirm reproducibility.5.19. The number of batches manufactured and the number of samples taken should be based on quality risk managementprinciples, allow the normal range of variation and trends to be established and provide sufficient data for evaluation. Each manufacturer must determine and justify the number of batches necessary to demonstrate a high level of assurance that the process is capable of consistently delivering quality product.5.20. Without prejudice to 5.19, it is generally considered acceptable that a minimum of three consecutive batches manufactured under routine conditions could constitute a validation of the process. An alternative number of batches may be justified taking into account whether standard methods of manufacture are used and whether similar products or processes are already used at the site. An initial validation exercise with three batches may need to be supplemented with further data obtained from subsequent batches as part of an on-going process verification exercise.5.21. A process validation protocol should be prepared which defines the critical process parameters (CPP), critical quality attributes(CQA) and the associated acceptance criteria which should be based on development data or documented process knowledge.5.22. Process validation protocols should include, but are not limited to the following:i. A short description of the process and a reference to the respective Master Batch Record;ii. Functions and responsibilities;iii. Summary of the CQAs to be investigated;iv. Summary of CPPs and their associated limits;v. Summary of other (non-critical) attributes and parameters which will be investigated or monitored during the validation activity, and the reasons for their inclusion;vi. List of the equipment/facilities to be used (including measuring/monitoring/recording equipment) together with the calibration status;vii. List of analytical methods and method validation, as appropriate.viii. Proposed in-process controls with acceptance criteria and the reason(s) why each in-process control is selected;ix. Additional testing to be carried out with acceptance criteria;x. Sampling plan and the rationale behind it;xi. Methods for recording and evaluating results;xii. Process for release and certification of batches (if applicable).Continuous process verification (5.23-5.25)5.23. For products developed by a quality by design approach, where it has been scientifically established during development that the established control strategy provides a high degree of assurance of product quality, then continuous process verification can be used as an alternative to traditional process validation.5.24. The method by which the process will be verified should be defined. There should be a science based control strategy for the required attributes for incoming materials, critical quality attributes and critical process parameters to confirm product realisation. This should also include regular evaluation of the control strategy. Process Analytical Technology and multivariate statistical process control may be used as tools. Each manufacturer must determine and justify the number of batches necessary to demonstrate a high level of assurance that the process is capable of consistently delivering quality product.5.25. The general principles laid down in 5.1 – 5.14 above still apply.Hybrid approach (5.26-5.27)5.26. A hybrid of the traditional approach and continuous process verification could be used where there is a substantial amount of product and process knowledge and understanding which has been gained from manufacturing experience and historical batch data.5.27. This approach may also be used for any validation activities after changes or during ongoing process verification even though the product was initially validated using a traditional approach.Ongoing Process Verification during Lifecycle (5.28-5.32)5.28. Paragraphs 5.28-5.32 are applicable to all three approaches to process validation mentioned above, i.e. traditional, continuous and hybrid.5.29. Manufacturers should monitor product quality to ensure that a state of control is maintained throughout the product lifecycle with the relevant process trends evaluated.5.30. The extent and frequency of ongoing process verification should be reviewed periodically. At any point throughout the product lifecycle, it may be appropriate to modify the requirements taking into account the current level of process understanding and process performance.5.31. Ongoing process verification should be conducted under an approved protocol or equivalent documents and a corresponding report should be prepared to document the results obtained. Statistical tools should be used, where appropriate, to support any conclusions with regard to the variability and capability of a given process and ensure a state of control.5.32. Ongoing process verification should be used throughout the product lifecycle to support the validated status of the product as documented in the Product Quality Review. Incremental changes over time should also be considered and the need for any additional actions, e.g. enhanced sampling, should be assessed.6. VERIFICATION OF TRANSPORTATION (6.1-6.4)6.1. Finished medicinal products, investigational medicinal products, bulk product and samples should be transported from manufacturing sites in accordance with the conditions defined in the marketing authorisation, the approved label, product specification file or as justified by the manufacturer.6.2. It is recognised that verification of transportation may be challenging due to the variable factors involved however, transportation routes should be clearly defined. Seasonal and other variations should also be considered during verification of transport.6.3. A risk assessment should be performed to consider the impact of variables in the transportation process other than those conditions which are continuously controlled or monitored, e.g. delays during transportation, failure of monitoring devices, topping up liquid nitrogen, product susceptibility and any other relevant factors.6.4. Due to the variable conditions expected during transportation, continuous monitoring and recording of any critical environmental conditions to which the product may be subjected should be performed, unless otherwise justified.7. VALIDATION OF PACKAGING (7.1-7.2)7.1. Variation in equipment processing parameters especially during primary packaging may have a significant impact on the integrity and correct functioning of the pack, e.g. blister strips, sachets and sterile components, therefore primary and secondary packaging equipment for finished and bulk products should be qualified.7.2. Qualification of the equipment used for primary packing should be carried out at the minimum and maximum operating ranges defined for the critical process parameters such as temperature, machine speed and sealing pressure or for any other factors.8. QUALIFICATION OF UTILITIES (8.1-8.3)8.1. The quality of steam, water, air, other gases etc. should be confirmed following installation using the qualification steps described in section 3 above.8.2. The period and extent of qualification should reflect any seasonal variations, if applicable, and the intended use of the utility.8.3. A risk assessment should be carried out where there may be direct contact with the product, e.g. heating, ventilation and air-conditioning (HVAC) systems, or indirect contact such as through heat exchangers to mitigate any risks of failure.9. VALIDATION OF TEST METHODS (9.1-9.3)9.1. All analytical test methods used in qualification, validation or cleaning exercises should be validated with an appropriate detection and quantification limit, where necessary, as defined in Chapter 6 of the EudraLex, Volume 4, Part I.9.2. Where microbial testing of product is carried out, the method should be validated to confirm that the product does not influence the recovery of microorganisms.9.3. Where microbial testing of surfaces in clean rooms is carried out, validation should be performed on the test method to confirm that sanitising agents do not influence the recovery of microorganisms.10. CLEANING VALIDATION (10.1-10.15)10.1. Cleaning validation should be performed in order to confirm the effectiveness of any cleaning procedure for all product contact equipment. Simulating agents may be used with appropriate scientific justification. Where similar types of equipment are grouped together, a justification of the specific equipment selected for cleaning validation is expected.10.2. A visual check for cleanliness is an important part of the acceptance criteria for cleaning validation. It is not generally acceptable for this criterion alone to be used. Repeated cleaning and retesting until acceptable residue results are obtained is not considered an acceptable approach.10.3. It is recognised that a cleaning validation programme may take some time to complete and validation with verification after each batch may be required for some products, e.g. investigational medicinal products. There should be sufficient data from the verification to support a conclusion that the equipment is clean and available for further use.10.4. Validation should consider the level of automation in the cleaning process. Where an automatic process is used, the specified normal operating range of the utilities and equipment should be validated.10.5. For all cleaning processes an assessment should be performed to determine the variable factors which influence cleaning effectiveness and performance, e.g.operators, the level of detail in procedures such as rinsing times etc. If variable factors have been identified, the worst case situations should be used as the basis for cleaning validation studies.10.6. Limits for the carryover of product residues should be based on a toxicological evaluation 1. The justification for the selected limits should be documented in a risk assessment which includes all the supporting references. Limits should be established for the removal of any cleaningagents used. Acceptance criteria should consider the potential cumulative effect of multiple items of equipment in the process equipment train.10.6.1.Therapeutic macromolecules and peptides are known to degrade and denature when exposed to pH extremes and/or heat, and may become pharmacologically inactive. A toxicological evaluation may therefore not be applicable in these circumstances.10.6.2.If it is not feasible to test for specific product residues, other representative parameters may be selected, e.g. total organic carbon (TOC) and conductivity.1 See EMA Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities10.7. The risk presented by microbial and endotoxin contamination should be considered during the development of cleaning validation protocols.10.8. The influence of the time between manufacture and cleaning and the time between cleaning and use should be taken into account to define dirty and clean hold times for the cleaning process.10.9. Where campaign manufacture is carried out, the impact on the ease of cleaning at the end of the campaign should be considered and the maximum length of a campaign (in time and/or number of batches) should be the basis for cleaning validationexercises.10.10. Where a worst case product approach is used as a cleaning validation model, a scientific rationale should be provided for the selection of the worst case product and the impact of new products to the site assessed. Criteria for determining the worst case may include solubility, cleanability, toxicity and potency.10.11. Cleaning validation protocols should specify or reference the locations to be sampled, the rationale for the selection of these locations and define the acceptance criteria.10.12. Sampling should be carried out by swabbing and/or rinsing or by other means depending on the production equipment. The sampling materials and method should not influence the result. Recovery should be shown to be possible from all product contact materials sampled in the equipment with all the sampling methods used.10.13. The cleaning procedure should be performed an appropriate number of times based on a risk assessment and meet the acceptance criteria in order to prove that the cleaning method is validated.10.14. Where a cleaning process is ineffective or is not appropriate for some equipment, dedicated equipment or other appropriate measures should be used for each product as indicated in chapters 3 and 5 of EudraLex, Volume 4, Part I.10.15. Where manual cleaning of equipment is performed, it is especially important that the effectiveness of the manual process should be confirmed at a justified frequency.1 See EMA Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities。
中国GMP附录-确认和验证-中英
附件1Annex 1确认与验证Qualification and Validation（征求意见稿）(Draft for Comments)第一章范围Chapter One Scope第一条本附录适用于《药品生产质量管理规范》中涉及的所有确认与验证活动。
Article 1 This appendix applies to all qualification and validation activities involved in Good Manufacturing Practice.第二章原则Chapter Two Principles第二条企业应当确定需要进行的确认或验证工作，以证明有关操作的关键要素能够得到有效控制。
确认和验证的范围和程度应根据风险评估的结果确认。
确认与验证应当贯穿于产品生命周期的全过程。
Article 2 A manufacturer should determine the required qualification or validation activities to prove that the critical aspects of relevant operations can be effectively controlled. The scope and extent of qualification and validation should be determined based on risk assessment results. Qualification and validation activities should be throughout the entire life cycle of a product.第三章验证计划Chapter Three Validation Plan第三条所有的确认与验证活动都应当事先计划。
确认与验证的关键要素都应在验证总计划或同类文件中详细说明。
美国药品生产质量管理规范-中英文对照
GOOD MANUFACTURE PRACTICE 美国药品生产质量管理规范（CGMP）二○○三年十二月目录210.1 cGMP法规的地位 (2)210.2 cGMP法规的适用性 (2)210.3 定义 (2)211-A- 总则 (4)211-B- 组织与人员 (4)211-C- 厂房和设施 (5)211-D- 设备 (7)211-E- 成份、药品容器和密封件的控制 (8)211-F- 生产和加工控制 (10)211-G- 包装和标签控制 (11)211-H- 贮存和销售 (13)211-I- 实验室控制 (14)211-J- 记录和报告 (16)211-K- 退回的药品和回收处理 (20)210部分—人用及兽用药品的生产、加工、包装或贮存的CGMPPart 210 - CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PROCESSING, PACKING, OR HOLDING OF DRUGS; GENERAL210.1 cGMP法规的地位§ 210.1 Status of current good manufacturing practice regulations.(a) 在本部分及21CFR 211—226部分中陈述的法规是在药品生产、加工、包装或贮存中使用的现行生产质量管理规范及使用的设施或控制的最低标准，以保证该药品符合联邦食品、药品及化妆品法对安全性的要求，具有均一性和效价(或含量)并符合或代表其生产过程的质量及纯度等特征。
(a) The regulations set forth in this part and in Parts 211 through 226 of this chapter contain the minimum current good manufacturing practice for methods to be used in, and the facilities or controls to be used for, the manufacture, processing, packing, or holding of a drug to assure that such drug meets the requirements of the act as to safety, and has the identity and strength and meets the quality and purity characteristics that it purports or is represented to possess.(b) 凡是在药品生产、加工、包装或贮存过程中存在任何不符合本部分及21CFR 211—226部分中陈述的法规的药品，依据联邦食品、药品及化妆品法501 (a)(2)-(B)，该药应被视为劣药，同时导致该事故发生的负责人应受相应的法规的制裁。
中英对照-产品设计和开发控制程序
Marketing Department is in charge of the communication with the customer before new product development, to ensure the adequacy and effectiveness of customer requirements. Submit the mission after obtaining the document (like technical specification) or drawing required by customer.
After Technical Department receives the documents from Marketing Department, organize to conduct the compliance review for product related requirements like technical requirements, parameters, appearance requirements, delivery, statutory and regulatory requirements. If pass the review, officially confirm it as a contract. "Contract Review Form" is approved by General Manager, after being approved, it could be confirmed as a new product, Marketing Department formally issue the "Design and Development Mission Form of New Product" or "Production Notification", distribute to Technical Department with customer documents together. It goes into design and development stage.
欧洲药典CEP证书修订更新规定指南中英对照版
欧洲药典CEP证书修订更新规定指南中英对照版Date of implementation: 1 March 2010Introduction:The holder of a Certificate of suitability shall inform the EDQM of any change to the information in the certification dossier by sending an application form and all necessary documents demonstrating that the conditions laid down in the present guideline are met.Classification of changesThe changes have been classified in three categories (notification/minor/major) depending on the potential impact of the change on the quality of the final substance. These three categories are based on those (IA-IAIN/IB/II) of the Commission Regulation (EC) No 1234/2008 concerning the examination of variations to the terms of marketing authorisation for medicinal products for human use and veterinary medicinal products.Any change not classified as a notification or a major change should be classified as a minor change except in the following cases where a new application should be submitted:- addition of a new route of synthesis and/or a new manufacturing site where the specifications of the final substance are different from the one already approved- transfer to a new holder that is not the same legal entity as the approved one, where the transfer does not occur because of a merger or because the company is sold, and where the manufacturer does not take out the Certificate of suitability in their own name.The changes related to Ph. Eur. monograph revisions or any other regulatory requirements are treated separately andgenerally initiated by the EDQM.执行日期：2010年3月1日介绍：欧洲药典适用性证书持有人必须向EDQM报告所有与申报文件有关的变更，申报时应填写申请表格和所有必要的资料，证明变更符合现行指南的规定。
生物制品验证指导原则
生物制品验证指导原则英文回答：The principles for validating biological products are essential to ensure their safety, efficacy, and quality. As a regulatory professional in the biopharmaceutical industry, I have extensive experience in following these guidelines. Let me share with you some of the key principles for validating biological products.Firstly, it is crucial to establish a comprehensive validation plan that outlines the specific requirements and objectives of the validation process. This plan should include the scope of the validation, the acceptancecriteria, and the testing methods to be employed. For example, when validating a new vaccine, the plan would outline the necessary tests to assess its efficacy, such as immunogenicity studies in animal models and clinical trials in humans.Secondly, a risk-based approach should be adopted when designing the validation studies. This means that the level of validation required should be proportional to the potential risks associated with the product. For instance, if a biological product is intended for use in critically ill patients, more extensive validation studies may be necessary to ensure its safety and efficacy. On the other hand, if a product is classified as low-risk, a simplified validation approach may be appropriate.Thirdly, validation studies should be conducted using appropriate and validated methods. This ensures that the results obtained are accurate and reliable. For example, when validating the manufacturing process of a monoclonal antibody, analytical methods such as high-performanceliquid chromatography (HPLC) should be used to assess the product's purity and potency.Furthermore, it is important to establish a robust system for documenting and reporting the validation activities. This includes maintaining detailed records of all validation experiments, including the protocols, rawdata, and analysis reports. These records serve as evidence of compliance with regulatory requirements and can be reviewed by regulatory authorities during inspections.Lastly, validation is an ongoing process that should be periodically reviewed and updated as necessary. This is particularly important for biological products due to their inherent complexity and variability. For example, if a manufacturing process undergoes any changes, the validation studies should be repeated to ensure that the product remains safe and effective.中文回答：生物制品验证的原则对于确保其安全性、疗效和质量至关重要。
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。
Software engineering can be divided into ten disciplines
Software engineering can be divided into ten disciplines.▪Software requirements: The elicitation, analysis, specification, and validation of requirements for software.▪Software design: The design of software is usually done with Computer-Aided Software Engineering (CASE) tools and use standards for the format, such as the Unified Modeling Language (UML).▪Software development: The construction of software through the use of programming languages. ▪Software testing▪Software maintenance: Software systems often have problems and need enhancements for a long time after they are first completed. This subfield deals with those problems.▪Software configuration management: Since software systems are very complex, their configuration (such as versioning and source control) have to be managed in a standardized and structured method.▪Software engineering management: The management of software systems borrows heavily from project management, but there are nuances encountered in software not seen in othermanagement disciplines.▪Software development process: The process of building software is hotly debated among practitioners with the main paradigms being agile or waterfall.▪Software engineering tools, see Computer Aided Software Engineering▪Software qualitySoftware Life cycleSoftware Engineering MethodologiesA software development methodology refers to the framework that is used to structure, plan, and control the process of developing an information system.▪Waterfall: linear framework type.▪Prototyping: iterative framework type▪Incremental: combination of linear and iterative framework type▪Spiral: combination linear and iterative framework type▪Rapid Application Development (RAD): Iterative Framework TypeWaterfall modelThe waterfall model is a sequential development process.Basic principles of the waterfall model are:[▪Project is divided into sequential phases, with some overlap and splashback acceptable between phases.▪Emphasis is on planning, time schedules, target dates, budgets and implementation of an entire system at one time.PrototypingBasic principles of prototyping are▪Not a standalone, complete development methodology, but rather an approach to handling selected portions of a larger, more traditional development methodology (i.e. Incremental, Spiral, or Rapid Application Development (RAD)).▪Attempts to reduce inherent project risk by breaking a project into smaller segments and providing more ease-of-change during the development process.▪User is involved throughout the process, which increases the likelihood of user acceptance of the final implementation.▪Small-scale mock-ups of the system are developed following an iterative modification process until the prototype evolves to meet the users’ requirements.The spiral model is a software development process combining elements of both design and prototyping-in-stages, in an effort to combine advantages of top-down and bottom-up concepts. Basic principles:[1]▪Focus is on risk assessment and on minimizing project risk by breaking a project into smaller segments and providing more ease-of-change during the development process, as well as providing the opportunity to evaluate risks and weigh consideration of project continuation throughout the life cycle.▪"Each cycle involves a progression through the same sequence of steps, for each portion of the product and for each of its levels of elaboration, from an overall concept-of-operation document down to the coding of each individual program."[4]▪Each trip around the spiral traverses four basic quadrants: (1) determine objectives, alternatives, and constraints of the iteration; (2) Evaluate alternatives; Identify and resolve risks; (3) develop and verify deliverables from the iteration; and (4) plan the next iteration.[5]▪Begin each cycle with an identification of stakeholders and their win conditions, and end each cycle with review and commitment.[6]。
原料药车间清洁验证方案-中英文
某原料药公司原料药车间清洁验证方案Index 目录1 Introduction 介绍 (3)2 Purpose目的 (3)3 Scope范围 (4)4 Responsibilities职责 (5)5 Regulations and Guidance法规和指南 (6)6 Reference Documents参考文件 (7)7 Abbreviations缩略语 (7)8 Documentation Control Specification文件管理规范 (8)9 System Description系统描述 (8)10 Risk Analysis风险分析 (10)11 Sampling Procedure取样程序 (26)12 Acceptance Criteria可接受标准 (32)13 Analytical Method分析方法 (34)14 Validation and Test Method Specification验证说明及检测方法说明 (36)15 Precautions and Responsibilities During CV清洁验证过程中的注意事项和责任分工 (37)16 Monitor and Re-validation Stage监控及再验证阶段 (38)17 Prerequisites for Validation验证先决条件 (38)18 Cleaning Validation Execution清洁验证执行 (43)19 Deviation Handling偏差处理 (55)20 Change Handling变更处理 (56)21 CV Report清洁验证报告 (56)22 Attachment List附件清单 (56)23 Test Report List测试报告目录 (57)1Introduction 介绍This cleaning validation protocol mainly aims at preparing protocol for cleaning validation activity of the product produced in xxx. Cleaning validation ofcefotaxime will be performed after PQ of all processing equipment, HVACsystem, water system and utility system in XXXX API plant finished, andcleaning validation will synchronize with process validation. This cleaningvalidation protocol will describe the whole procedure of implementing cleaning validation of product. Equipment cleaning method involved in this XXXX API Plant mainly are off-line cleaning and manual cleaning, before conductingcleaning validation, must finish analytical method validation and cleaning process research related to cleaning validation of process equipment.本清洁验证方案主要针对XXXX原料药车间生产的产品所进行的清洁验证活动制定方案。
Specification, validation, and verification of time-critical systems
Abstract In this paper, we propose a new formalism, named the Timed Communicating Finite State Machine (Timed CFSM), for specifying and verifying time-critical systems. Timed CFSM preserves the advantages of CFSM, such as the ability to express communication, synchronization and concurrency in computer systems. A given time-dependent specification can be formalized as a Timed CFSM, from which the reachability graph is constructed to verify the correctness of the specification. To cope with the space explosion problem from which all reachability analysis methods suffer, we propose a space reduction algorithm to meet the space constraint of the verification environment. 0 1998 Elsevier Science B.V.
Departmenr of Cornpurer Science and Information Engineering, National Chiao Tung University, Hsinchu 30010, Taiwan
检验方法确认美国药典usp1225
验证: Validation 针对新方法(没有法定方法, 需要用户自己建立的) 按照ICH Q2 或USP<1225>的方式均可; 主要是需要满足使用目的.<1225>VALIDATION OF COMPENDIAL PROCEDURES药典规程的验证Test procedures for assessment of the quality levels of pharmaceutical articles are subject to various requirements. According to Section 501 of the Federal Food, Drug, and Cosmetic Act, assays and specifications in monographs of the United States Pharmacopeia and the National Formulary constitute legal standards. The Current Good Manufacturing Practice regulations [21 CFR 211.194(a)] require that test methods, which are used for assessing compliance of pharmaceutical articles with established specifications, must meet proper standards of accuracy and reliability. Also, according to these regulations [21 CFR 211.194(a)(2)], users of analytical methods described in USP-NF are not required to validate the accuracy and reliability of these methods, but merely verify their suitability under actual conditions of use. Recognizing the legal status of USP and NF standards, it is essential, therefore, that proposal for adoption of new or revised compendial analytical procedures be supported by sufficientlaboratory data to document their validity.评估药品质量水平的实验方法受到多种要求的影响。
PDA报告清单
1996（R2011）
23 Industry Survey on Current Sterile Filtration Practices
1996
24 Current Practices in the Validation of Aseptic Processing
1996
25 Blend Uniformity Analysis: Validation and In-Process Testing
52 Guidance for Good Distribution Practices for the Pharmaceutical Supply Chain
2011
53 Guidance for Industry: Stability Testing to Support Distribution of New Drug
1992
17 Current Practices in the Validation of Aseptic Processing
1993
18 Report on the Validation of Computer-Related Systems
1995
19 Rapid/Automated ID Methods Survey
2010
50 Alternative Methods for Mycoplasma Testing 51 Biological Indicators for Gas and Vapor-Phase Decontamination Processes：
2010 2010
Specification, Manufacture, Control and Use
1998（R2006）
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Specification and Validation of New Control Algorithms for Electric Drives using SpecC Language
Slim Ben Saoud, Daniel D. Gajski Technical Report ICS-01-44 July 25, 2001 Center for Embedded Computer Systems Department of Information and Computer Science University of California, Irvine Irvine, CA 92697-3425, USA (9lectrical Drives Specification Using SpecC ___________________________________5
4.1 Overview_______________________________________________________________5 4.2 Process Specification ______________________________________________________5 4.3 Control Device Specification ________________________________________________6 4.4 Case of D.C. System_______________________________________________________7
Specification and Validation of New Control Algorithms for Electric Drives using SpecC Language
Slim Ben Saoud, Daniel D. Gajski Technical Report ICS-01-44 July 25, 2001 Center for Embedded Computer Systems Department of Information and Computer Science University of California, Irvine Irvine, CA 92697-3425, USA (949) 824-8059
Today, the shortest time-to-market in the electric drives industries is being a pressing requirement, consequently development time of new algorithms and new control systems and debugging them must be minimized. This requirement can be satisfied only by using a well-defined System-level design methodology and by reducing the migration time between the algorithm development language and the hardware specification language. In this report, we propose to use the SpecC language for the development (specification and validation) of new control algorithms. This includes the specification of the control systems (algorithms and I/O interfaces) in SpecC and its validation by simulation using a SpecC specification model of the process under control. This new approach will allow designers to implement easily the retained specification according to the SpecC methodology. Indeed, the same language (SpecC) is used for the study of new control systems and their design and implementation. We first begin with a brief presentation of the electric drives and of the SpecC language. Then, we discuss the specification models in SpecC of the whole system including the control unit and the process under control. We illustrate this approach by an application example of a DC system. Finally, we present the main advantages of the SpecC language in the development of new control systems.
3.1 Design Consideration for System Level Design Language __________________________2 3.2 Traditional Languages_____________________________________________________3 3.3 SpecC Language _________________________________________________________3
Abstract
Contents
1 2 3 Introduction______________________________________________________________1 Electrical Drives __________________________________________________________2 SpecC Language __________________________________________________________2
Slim Ben Saoud Fulbright Visitor @ CECS INSAT-Tunis-TUNISIA sbensaou@ /~sbensaou
Daniel D. Gajski CECS UCI-California-USA gajski@ /~gajski
References __________________________________________________________________10 Appendix: SpecC code for the DC system ________________________________________11
4.4.1 4.4.2 4.4.3 DC Process_______________________________________________________________________________7 Digital Control Device _____________________________________________________________________8 Results ___________________________________________________________________________________8
5 6
SpecC Language Advantages________________________________________________9 Conclusion _______________________________________________________________9
Slim Ben Saoud Fulbright Visitor @ CECS INSAT-Tunis-TUNISIA sbensaou@ /~sbensaou
Daniel D. Gajski CECS UCI-California-USA gajski@ /~gajski
List of Figures
Figure 1: Electrical drive structure ____________________________________________________________ 2 Figure 2: Language Comparison_______________________________________________________________ 3 Figure 3: Basic structure of SpecC program______________________________________________________ 4 Figure 4: Behavioral hierarchy _______________________________________________________________ 4 Figure 5: Top-level specification model of electrical drive system _____________________________________ 5 Figure 6: Detailed specification model of electric drives systems ______________________________________ 6 Figure 7: Specification model of the control device ________________________________________________ 7 Figure 8: Specification model of a DC system ____________________________________________________ 7 Figure 9: OIE sensor Specifications____________________________________________________________ 7 Figure 10: Control device specification – case of DC system _________________________________________ 8 Figure 11: Specification model results __________________________________________________________ 8