国际无菌制药工程项目的系统化实施.doc

国际无菌制药工程项目的系统化实施 国际无菌制药工程项目的系统化实施 概要 l FDA/EU GMP法规及趋势 l 良好的工程规范 ?基于科学和工程基础及合乎逻辑 ?定量化 l 系统化地实施 ?多学科的协作 ?循序渐进的过程 l 拜耳技术工程的工程项目流程及执行 FDA cGMP ??21 CFR 210 and 211 ??e.g. 21 CFR 211.42(c) (10): ??Aseptic processing: which includes as appropriate: (I) floors, walls and ceilings of smooth, hard surfaces that are easily cleanable; ??(ii) temperature and humidity controls; ??(iii) an air supply filtered through high-efficiency particulate air filters under positive pressures ??(iv) a system for monitoring environmental conditions ??(v) a system for cleaning and disinfecting the room and equipment to produce aseptic conditions ??(vi) a system for maintaining any equipment used to control the aseptic conditions. 相关指南及参考 ??Guidance for industry – Sterile Drug Products Produced by Aseptic Processing – cGMP ??FDA, 2004 ??Intended to help manufacturers meet the requirements in cGMP (21 CFR Parts 210 and 211) using aseptic processing ??Relating to facility design, equipment suitability, process validation, and quality control ??FDA Guide to Inspections of Lyophilization of Parenterals ??ISPE Baseline Pharmaceutical Engineering Guide EU GMP ??EU: 2003/94/EC: principles and guidelines of GMP ??EU GMP Guide Part I, Part II, and Annexes ?Annex 1 - Manufacture of Sterile Medicinal Products 21世纪的cGMP ??Current ??Strict change management due to lack of process understanding ??Quality by test ??2-3 sigma ??Sound science and engineering base ??Promotes innovation ??Encourages use of new technologies ??Incorporates risk-based approaches ??Promotes Quality by Design ??Process predictability is the major theme of 21st Century cGMP 无菌生产 ??Aseptic processing facility – (FDA) ??A building, or segregated segment of it, containing clean rooms in which air supply, materials, and equipment are regulated to control microbial and particle contamination... ??True test to the conformance of cGMP 关键控制点 ??Causes of contamination ?What are the potential routes of contamination in an aseptic process? ??Co