WHO原料药GMP现场检查(中英文)

1、Module 14Slide 1 of 23WHO - EDMBasic Principles of GMP GMP基本准则Active Pharmaceutical Ingredients 原料药原料药Part Three, 18Module 14Slide 2 of 23WHO - EDMActive Pharmaceutical Ingredients原料药Objectives 目的目的lTo discuss the GMP guidelines for the manufacture of Active Pharmaceutical Ingredients (APIs)l讨论用于指导A

2、PI生产的GMP指南lTo examine key problems experienced during inspections of the manufacturers of APIs and to seek possible solutionsl针对API生产GMP检查过程中所发现关键问题的检查，并寻求可能的解决方案Part Three, 18.118.59Module 14Slide 3 of 23WHO - EDMActive Pharmaceutical Ingredients 原料药Areas to be Covered 涉及范围涉及范围lGeneral consideratio

3、ns总则lPersonnel人员lPremises厂房设施lEquipment设备lSanitation卫生lDocumentation文件系统lRetention of records and samples记录和样品的保存lProduction生产Part Three, 18.118.59Module 14Slide 4 of 23WHO - EDMActive Pharmaceutical Ingredients 原料药General Considerations总则总则lOverall control全面控制lConsistent uniform batches批一致性和均匀性lCom

4、pliance with GMP GMP符合性 Production 生产 quality control 质量控制lGeneral guidelines 总指南lCo-operation in production协作生产lHuman and veterinary preparations人药和兽药的制备Part Three, 18.118.6Module 14Slide 5 of 23WHO - EDMActive Pharmaceutical Ingredients原料药Personnel 人员人员lQualified and competent资历和资格 production and

5、quality control 生产和质量控制 sufficient number足够数量 education, knowledge, experience学历、知识和经验lOrganizational chart with responsibilities组织机构图（包含相关职责）lWritten job description or instructions书面职位描述或说明lTrained 接受培训情况lHealth健康情况 Diseases疾病 open lesions开放性伤口Part Three, 18.718.10Module 14Slide 6 of 23WHO - EDMAc

6、tive Pharmaceutical Ingredients原料药Premises厂房设施厂房设施lGeneral总则 suitable construction and environment适宜建筑和环境 adequately adapted and sufficient size充分、适宜和足够的空间 mix-ups or contamination混淆或污染控制 logical work flow合理的工作流程lSpecial purposes特殊要求 antibiotics, hormones, cytostatic substances抗菌、激素和细胞产品 separate sp

7、ecifically designed enclosed areas独立、特别设计的密闭区域 separate air handling systems独立的空气处理系统Part Three, 18.1118.13Module 14Slide 7 of 23WHO - EDMActive Pharmaceutical Ingredients原料药Premises厂房设施厂房设施lHygiene卫生 clothes, washing, toilets着装、清洗和盥洗 eating, drinking, smoking吃东西、喝饮料和吸烟Part Three, 18.1118.13Module 1

8、4Slide 8 of 23WHO - EDMActive Pharmaceutical Ingredients原料药Equipment设备设备lDesign, construction, location and maintenance设计、建造、定位和维护 intended use, cleaning, contamination用途、清洗、污染控制 validated operation 经验证的操作lCleaning清洗 sterilised, used, maintained: SOPs, records and checks灭菌、使用、维护：SOP、记录和复核Part Three,

9、 18.1418.18Module 14Slide 9 of 23WHO - EDMActive Pharmaceutical Ingredients原料药Equipment设备设备lProcess monitoring and control工艺监控 calibrated, checked 校验、复核 Records记录lDefective equipment 不合格设备 removed or labelled移走或标识 repaired, documented维修并记录Part Three, 18.1418.18Module 14Slide 10 of 23WHO - EDMActive

10、Pharmaceutical Ingredients原料药Sanitation卫生卫生lWritten programmes书面程序 validated for premises and equipment厂房设施和设备的验证 quality standard for water水质质量标准 hygiene , health and clothing practices卫生、健康和着装规范 waste disposal废物处理lImplementation and training实施与培训lPractices not permitted:不允许的行为： eating, smoking 吃东西

11、和吸烟 unhygienic practices不卫生行为Part Three, 18.1918.22Module 14Slide 11 of 23WHO - EDMActive Pharmaceutical Ingredients原料药Documentation文件系统文件系统lMaster formulae主要规则 written instructions书面指令 master formula contents主要规则内容 Authorisation授权 outdated documents过期文件处理 Amendments文件修订lBatch documentation批生产文件 bat

12、ch manufacturing record contents批生产记录内容 contract production合同生产 data recording数据记录Part Three, 18.2318.30Module 14Slide 12 of 23WHO - EDMActive Pharmaceutical Ingredients原料药Record and reference sample retention留样记录和留样记录和查阅查阅lActivities are traceable一切行为可追踪 production and quality control生产和质量控制lRetent

13、ion of records and samples记录和样品的保存 retention period保存期Part Three, 18.3118.32Module 14Slide 13 of 23WHO - EDMActive Pharmaceutical Ingredients原料药Production生产生产lProcessing procedures工艺处理程序 master formula主配方 critical steps defined and validated关键步骤的确定和验证 Supervision监管 Labelling贴标 vessels, containers, e

14、quipment反应罐、容器、设备 daily activities information日常活动信息Part Three, 18.3318.37Module 14Slide 14 of 23WHO - EDMActive Pharmaceutical Ingredients原料药Production (continued)生产（接上）lStarting materials起始物料 receiving, quarantine, sampling接收、待检和取样 Testing检测 release, reject, storage, labelling放行、拒收、贮存和标识 dispensin

15、g SOP 分发SOP exceptions for hazardous materials危险物品的特别管理lIntermediates中间体 Testing检测 Labelling标贴 Storage贮存Part Three, 18.3818.40Module 14Slide 15 of 23WHO - EDMActive Pharmaceutical Ingredients原料药Production (continued)生产（接上）Active pharmaceutical ingredients原料药 meet specifications符合质量标准 limits for resi

16、due and reactants残留和反应物的限量 sterile APIs无菌原料药Part Three, 18.4118.42Module 14Slide 16 of 23WHO - EDMActive Pharmaceutical Ingredients原料药Production (continued)生产（接上）lPackaging包装 packaging material selection包材选择 procedures to prevent error预防差错的程序 labelling, including:标贴，包括： Product name产品名称 Quality质量 Ba

17、tch number批号 Expiry or retest date有效期或复检期 Warnings, if required警示，必要时 Storage conditions贮存条件 Names of manufacturers and suppliers生产商和供应商名称Part Three, 18.4318.45Module 14Slide 17 of 23WHO - EDMActive Pharmaceutical Ingredients原料药Quality Control质量控制质量控制lIndependent unit独立单位lDuties: Approve, reject or

18、release职责：批准、放行或不放行 specifications and methods质量标准和检测方法 sampling, sanitation and hygiene取样、卫生设施和卫生 Reprocessing返工 Stability稳定性 Complaints投诉lLaboratory access and requirements实验室进入及其要求lContract laboratories合同实验室Part Three, 18.4618.51Module 14Slide 18 of 23WHO - EDMActive Pharmaceutical Ingredients原料药

19、Stability Studies稳定性研究稳定性研究lWritten programme书面程序 stability indicating methods稳定性试验（表明稳定性试验方法）lSamples取样 Containers容器 storage conditions贮存条件lExpiry or retest date有效期或复检期Part Three, 18.4618.51Module 14Slide 19 of 23WHO - EDMActive Pharmaceutical Ingredients原料药Self-Inspection and Quality Audits自检和质量审自

20、检和质量审计计lRegular independent inspection常规独立审计 expert or team of experts专家或专家组 production and quality control生产和质量控制lRecords记录Storage贮存贮存lSuitable conditions based on stability studies基于稳定性研究的适宜条件lDistribution records for each batch每批分发记录 written SOP书面SOP facilitate recalls推进召回程序Part Three, 18.5218.55

21、Module 14Slide 20 of 23WHO - EDMActive Pharmaceutical Ingredients原料药Complaints and Defects投诉和缺陷投诉和缺陷lWritten instructions书面指令lPrompt action and investigation迅速行动和调查 record facts 记录事实lProduct review system产品质量回顾系统Reject materials不合格物料不合格物料lWritten procedures书面程序 starting materials, intermediates, pac

22、kaging materials起始物料、中间体、包材 Identified 识别 storage pending fate贮存等待处理Part Three, 18.5618.59Module 14Slide 21 of 23WHO - EDMActive Pharmaceutical Ingredients原料药Group Session团体会议团体会议lIdentify major deficiencies experienced in GMP in active pharmaceutical ingredients manufacture.识别原料药生产GMP管理中的主要缺陷lAre there any deficiencies that should prevent material being released?是否有阻止物料放行的缺陷？lWithin what timescale should these deficiencies be corrected? 该类缺陷的整改期限？lWhat are the implications for bulk active supply to your country? 大宗原料药供应到你们国家的政策？Mo