WHO原料药GMP现场检查(中英文).ppt

Basic Principles of GMP GMP基本准则 Active Pharmaceutical Ingredients 原料药 Active Pharmaceutical Ingredients原料药 Objectives 目的 To discuss the GMP guidelines for the manufacture of Active Pharmaceutical Ingredients (APIs) 讨论用于指导API生产的GMP指南 To examine key problems experienced during inspections of the manufacturers of APIs and to seek possible solutions 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 Active Pharmaceutical Ingredients 原料药 Areas to be Covered 涉及范围 General considerations总则 Personnel人员 Premises厂房设施 Equipment设备 Sanitation卫生 Documentation文件系统 Retention of records and samples记录和样品的保存 Production生产 Active Pharmaceutical Ingredients 原料药 General Considerations总则 Overall control全面控制 Consistent uniform batches批一致性和均匀性 Compliance with GMP GMP符合性 Production 生产 quality control 质量控制 General guidelines 总指南 Co-operation in production协作生产 Human and veterinary preparations人药和兽药的制备 Active Pharmaceutical Ingredients原料药 Personnel 人员 Qualified and competent资历和资格 production and 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 Organizational chart with responsibilities组织机构图（包含相关职责） Written job description or instructions书面职位描述或说明 Trained 接受培训情况 Health健康情况 Diseases疾病 open lesions开放性伤口 Active Pharmaceutical Ingredients原料药 Premises厂房设施 General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 Special purposes特殊要求 antibiotics, hormones, cytostatic substances抗菌、激素和细胞产品 separate specifically 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 Active Pharmaceutical Ingredients原料药 Premises厂房设施 Hygiene卫生 clothes, washing, toilets着装、清洗和盥洗 eating, drinking, smoking吃东西、喝饮料和吸烟 Active Pharmaceutical Ingredients原料药 Equipment设备 Design, 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 Cleaning清洗 sterilised, used, maintained: SOPs, records and checks灭菌、使用、维护：SOP、记录和复核