cGMP对无菌药品的要求.pptVIP

Intl Reg Bus Cons 09validnsfda4.fdacgmpsterile cGMP for Sterile Drug Products and APIs无菌药品和原料药的cGMP Presentation by Ira R. Berry International Regulatory Business Consultants, L.L.C. Maplewood, New Jersey, USA Draft Guidance – Aseptic ProcessingI. Introduction无菌工艺指南（讨论稿）介绍 Use with 1994 guidance 使用1994版指南 Covers facility design, equipment suitability, process validation, quality control 覆盖了设施设计、设备适用性、工艺验证、质量控制内容 Draft Guidance - II. Background指南讨论稿-II.背景 Aseptic processing 无菌工艺 Terminal sterilization 最终灭菌 Draft Guidance – III. Scope指南讨论稿- III. 范围 Finished drug products 成品 Upstream bulk processing steps 原料药上游的工艺步骤 Terminal sterilization not covered 不包括最终灭菌 Draft Guidance – IV. Buildings and Facilities指南讨论稿- IV. 厂房和设施 Separate and controlled areas 单独和控制区 Microbiological and particle standards 微生物和尘埃粒子标准 Evaluate under static and dynamic conditions 静态和动态条件下的评估 Critical Area = Class 100关键区域＝100级 Sterilized drug product, containers, closures exposed to environment = maintain sterility 灭菌的药品、容器、密封暴露于环境＝保持无菌 Design air handling system 空调系统的设计 Personnel practices and procedures 人员行为和操作程序 Personnel flow 人流 Monitor daily 每日的监控 Air Handling System 空调系统 HEPA filtered and laminar flow (HEPA过滤和层流） Retain NLT 99.97% particulates 0.3 micron Leak test – introduce upstream challenge – installation, every 6 months – dioctylphthalate (DOP) and polyalphaolefin (PAO) aerosols 泄漏测试－－上游挑战性试验： 用邻苯二甲酸二辛脂或聚α烯烃气溶胶每半年测定。 Monitor face velocity检测表面速率 Air Handling System 空调系统 Carry particles from closing area从密封区携带微粒 Unidirectional air flow 单向流 Constant flow 恒流 Conduct air pattern analysis气流样式分析 HEPA（HIGH EFFCIENCY PARTICULATE AIR ） HEPA（高效空气微粒子过滤）是具有世界统一标准的过滤器，对0.3微米以上的微粒子的过滤效率达到99.97%以上。 Supporting Clean Area =Class 100,000支持性的洁净区＝100000级 Non-sterile components, products, materials, equipment, containers and closures - prepared, stored or transferred 非无菌组分、产品、材料、设备、容器和密封材料－－制备、贮存或转移 Minimize particle contamination 将粒子污染减至最小 Control micr