[工程科技]中英文美国FDA GMP检查.ppt

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1、Conducting an FDA Inspection执行FDA检查Inspections检查检查 Are FACT finding in nature 是事实性的调查结果 Require EVIDENCE 需要证据证据 Are REGUALTORY in nature 实质上是一种监管监管 What is said could end up in court 所说的内容可能最终会在法庭上裁决 Require ORGANIZATION and TIME MANAGEMENT 需要组织组织和时间管理时间管理Objectives of Inspection检查的目标检查的目标 Conduct t

2、he inspection in accordance with FD&C Act and Current Good Manufacturing Practice(CGMP)Regulations 检查的执行依据联邦食品，药品和化妆品法(FD&C Act)及现行药品生产管理规范(CGMP)条例 Accomplish what is necessary per the established,supporting Compliance Policy Guidance Manual 检查执行的程度依据 符合性方针指导手册符合性方针指导手册 7356.002“Drug Manufacturing I

3、nspections”7356.002“药品生产检查”“Systems Approach”“系统化方法”Accomplish necessary,additional questions/concerns listed in the inspection assignment(“For Cause”Inspection)要完成必要的检查、其它问题/额外关注点见“追因”检查的检查任务分配The Law says.法律规定法律规定.“A drug shall be deemed adulterated if:“一种药品应当被视为一种药品应当被视为掺假药品掺假药品，如果：如果：.the method

4、s used in,or the facilities or controls used for,its manufacture,processing,packing,or holding do not conform to or are not operated or administered in conformity with current good manufacturing practice.”使用于制造、加工、包装或置放的方法或设施、控制装置不符合或使用于制造、加工、包装或置放的方法或设施、控制装置不符合或没有遵照在安全性上保证药品符合现行没有遵照在安全性上保证药品符合现行GMP

5、的规定的规定”The Law says法律规定法律规定.“to assure that such drug meets the requirements of this Act as to safety and has the identity and strength,and meets the quality and purity characteristics,which it purports or is represented to possess.”“并保证符合其声称或据称的鉴别和含量、质量和纯度特征的现行药品生产质量管理规范操作和管理。”The CGMP Regulation C

6、GMP法规法规 Current Good Manufacturing Practice for Finished Pharmaceuticals 对于成品药的现行药品生产管理规范（CGMP）21 CFR Parts 210 and 211 Substantive实质性 Force and effect of law 法律效力The CGMP Regulation CGMP 法规法规CGMP for Finished Pharmaceuticals 对于成品药的现行药品生产管理规范（CGMP）21 CFR Parts 210 and 211 Establish“what to”do,not“ho

7、w to”确定“要做什么,而不是“如何做”Minimal standards 最低标准 Maximum flexibility 最大的灵活性 Specific enough to address problems 具体到足以解决问题 e.g.,Penicillin contamination control 例如，青霉素污染控制 Technology neutral 技术中立 Scalable 可扩展性Conducting an FDA Inspection:Objectives进行进行FDA检查的目标检查的目标“Systems Approach”“系统化方法”6 systems overvi

8、ew 6大系统概述 Type of coverage:覆盖类型:Records we audit/review 记录审计/审评的内容 Operations/practices 操作/规范Explain how to identify and document inspection observations 讲解如何确定和记录检查到的内容Compliance Program Guidance Manual 符合性项目指南手册符合性项目指南手册7356.002 “Drug Manufacturing Inspections”“药品生产检查药品生产检查”“Systems Approach”“系统化方

9、法”Quality System 质量体系质量体系Facilities and Equipment System 设施和设备系统设施和设备系统Materials System 物料体系物料体系Production System 生产体系生产体系Packaging and Labeling System 包装和标签体系包装和标签体系Laboratory Control System 实验室控制体系实验室控制体系http:/www.fda.gov/AboutFDA/CentersOffices/CDER/ucm095598.htmWhat type of inspection can be don

10、e?可以进行什么类型的检查？可以进行什么类型的检查？Full Inspection Option 全面检查方案 Quality System plus(at least)three other systems 质量体系质量体系加（至少）三个三个其他系统Abbreviated Inspection Option 简化检查方案 Quality System plus one other system 质量体系质量体系加一个一个其他系统Packaging&Labeling包装和标签Laboratory实验室Facilities&Equipment设施及设备Production生产Materials物

11、料Records记录记录Tools for control of highly-variable parts of the manufacturing processHUMANS 用以控制生产过程中具有高变化性的那一部分用以控制生产过程中具有高变化性的那一部分.人类人类“If you didnt document it,then it didnt happen”“没有记录，就没有发生没有记录，就没有发生”Requirements in 21 CFR 211 21 CFR 211要求要求Records记录记录As part of the inspection process 作为检验工作的一部分

12、作为检验工作的一部分 Records are a cornerstone for evaluation of compliance with CGMP 记录是检查记录是检查CGMP符合性的基础符合性的基础Records记录记录Standard Operating Procedures(SOPs)标准操作规程（标准操作规程（SOP）Provide instructions for 为为提供指示提供指示 Completing the task 完成任务完成任务 Completing the associated documentation 完成相关的文档完成相关的文档 (the bulk of r

13、ecord review)(大量的记录审查大量的记录审查)More Records更多的记录更多的记录Process Validation 工艺验证工艺验证Equipment Qualification 设备确认设备确认Computer System Validation 计算机系统验证计算机系统验证(Protocol and Executed Protocol)(方案和已执行方案方案和已执行方案)Quality System质量体系质量体系Annual Product Reviews(APRs)年度产品回顾（APR）Summary综述 Specific information require

14、d by 21 CFR 211 21 CFR 211要求的具体信息 Trends “Snapshot 趋势 “快照”Complaints 投诉 Procedures define responsibilities 建立规程明确责任 Investigation Reports 调查报告Quality System cont.质量体系质量体系 续续Deviations(Non-Conformances)/OOS 偏差（不合格项）/超规 SOPs define responsibilities 建立SOP明确责任 Investigation Reports 调查报告 Conclusions Fina

15、l Disposition 结论-最后处置Change Control 变更控制 Associated documentation referenced throughout the inspection(record review)在整个检查引用的相关文件(记录评审)Facilities and Equipment System设施和设备系统设施和设备系统Facilities设施设施 Major considerations when evaluating aseptic processing operations 对无菌工艺操作评估需要重要考虑的因素Building Management

16、System(BMS)建筑管理系统（建筑管理系统（BMS）Environmental Controls(Temp,RH,DP)环境控制（温度、湿度、压差）Qualification of System 系统确认系统确认 Maintenance/Calibration of system and sensors 系统和传感器的维护系统和传感器的维护/校准校准Facilities and Equipment System设施和设备系统设施和设备系统 Equipment设备设备 Qualification 确认确认 Initial 初始确认初始确认 Re-evaluation-after changes 再确认再确认-变更发生后变更发生后 *(Change Control Documentation)*(变更控制文件变更控制文件)Preventive Maintenance/Calibration 预防性维护预防性维护/校准校准 SOP dictates schedule or software program SOP规程规程或软件程序或软件程序 Outside Contract?合同外合同