药品生产企业GMP验证培训.ppt

THE PHARMACEUTICAL INDUSTRIES EXPECTATIONS OF INSPECTIONS BY REGULATORY AUTHORITIES 管理机构对制药企业认证检查展望 David C Donald Global Industrial Quality International Sites The Expertise of the Inspectors检查员的专业技术 Inspectors should have previous training and practical experience in manufacture, quality control and quality assurance of pharmaceutical products 检查员须经培训及具有制药企业生产，质控及质保等方面的实际工作经验 Deficiencies in experience needs in-house training; attendance at courses; seminars 经验上的不足需要加强内部培训，上课及参加研讨会 A thorough knowledge is needed in aspects of the pharmaceutical industry 完整的业内知识需涉及制药行业的所有领域 The Role of the Inspectors检查员的任务 Prime responsibility to produce a factual report on the standards of Good Manufacturing Practice (GMP)主要职责是以GMP为标准书写一份反映实际情况的报告 Assist Manufacturers to comply with GMP帮助企业更好地执行GMP Identify deficiencies in GMP鉴定GMP执行过程中的缺陷 Give advice on ways to correct deficiencies对纠正缺陷的方法提出指导 Accept alternative ways of compliance接受与GMP要求相符的其他选择方法 Regulatory Inspection Preparation准备检查 The planning, organisation, method of working and format of the final report is determined by the objective of the inspection在检查目的中应明确检查计划，组织，工作方法和报告的格式制定 Inspections of Manufacturers 生产企业的检查 Formulation, Filling and Packaging Operations 配方，分包装操作 Contract Testing Laboratories 委托检测的实验室 Blood Products 血制品 Pre-Approval Inspections (PAI’s) 批准前检查 Licence Variations; Adverse Events etc 许可证变更，不良反应事件 Types of Inspection检查类型 Routine Manufacturer’s Inspection常规生产企业的检查 - An inspection to satisfy the licensing authority that the manufacturer is in compliance with his licence and meets the GMP requirements对生产企业许可证的检查以确认该证的符合度及是否与GMP要求相一致 - for newly established facilities对新建设施的检查 - new product lines对新建生产线的检查 - changes in key personnel or equipment对主要人员或设备变更的检查 Types of Inspection检查类型 Follow-up Inspection跟踪检查 - the first inspection is incomplete第一次检查不彻底 - the Company has major deficiencies发现企业存在严重缺陷 Product Related Inspection与制品相关的检查 - to assess compliance of the Manufacturers’ operations w