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1、洁净空调系统验证,Validation of HVAC System,- Macroprocess -,主题,国内外有关法规和指南 Regulation and Guidance HVAC系统的要点 Key points of HVAC system 验证内容 Qualification Content,法规和指南 Regulation and Guidance,(SFDA) Good Manufacturing Practice, revised in 1998 (SFDA) 1998年版GMP European Commission. The Rules Governing Medicin
2、al Product in the European Union, Vol. IV, Good Manufacturing Practices. Medicinal products for human and veterinary use. 欧盟药品法规第4卷GMP（人用和兽用药品） Annex 1 to the EU Guide to Good Manufacturing Practice, Manufacture Of Sterile Medicinal Products. 2003 Edition. 欧盟GMP的附录1-无菌药品的生产，2003版 Annex 15 to the EU
3、Guide to Good Manufacturing Practice “Validation and Qualification” 欧盟GMP的附录15-验证和确认,法规和指南 Regulation and Guidance,(FDA) Title 21, Code of Federal Regulations, Part 210, Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs; General. (FDA) 联邦法规第21篇第210部分，有关药品
4、生产、加工、包装和贮存的CGMP总则 (FDA) Title 21, Code of Federal Regulations, Part 211, Current Good Manufacturing Practice for Finished Pharmaceuticals. (FDA) 联邦法规第21篇第211部分，成品药的现行生产质量管理规范 (FDA) Title 21, Code of Federal Regulations, Part 11, Electronic Records; Electronic Signature. (FDA）联邦法规第21篇第11部分，电子记录和电子签名
5、 (FDA) Guideline on Sterile Drug Products Produced by Aseptic Processing, September 2004 (FDA）无菌工艺的无菌药品生产的指南，2004年9月,法规和指南 Regulation and Guidance,ISPE Pharmaceutical Engineering Guides: ISPE制药工程指南： Volume 1: Bulk Pharmaceutical Chemical Facilities 卷一：化学原料药厂房 Volume 2: Oral Solid Dosage Forms 卷二：口服固
6、体制剂 Volume 3: Sterile Manufacturing Facilities 卷三：无菌生产厂房 Volume 5: Commissioning and Qualification 卷五：调试和确认 Volume 6: Biopharmaceutics 卷六：生物制药,法规和指南 Regulation and Guidance,ISO 14644 Clean Room Standard ISO 14644洁净室标准 Part 1: Classification of air cleanliness 第一部份：空气洁净度分类 Part 2: Specifications for
7、testing and monitoring 第二部分：测试和监视的标准 Part 3: Test Methods 第三部分：测试方法 Part 4: Design, Construction and Start-up 第四部分：设计、施工和启动,国内外GMP法规和指南的异同点,GMP条款都是原则性的 如：FDA cGMP 211.42(b) Any such building shall have adequate space for the orderly placement of equipment and materials to prevent mixups between diff
8、erent components, drug product containers, closures, labeling, in-process materials, or drug products, and to prevent contamination. 211.63 Equipment used in the manufacture, processing, packing, or holding of a drug product shall be of appropriate design, adequate size, and suitably located to faci
9、litate operations for its intended use and for its cleaning and maintenance.,国内外GMP法规和指南的异同点,欧美有一系列具体GMP实施或检查指南 如：FDA有” Guidance for Industry”和“Guide to Inspection”, 有“水系统”、“口服制剂”、“无菌工艺制剂”、“原料药”、“冻干制剂”、“清洗制剂”、“无菌原料药”等等方面的指南。 欧盟EMEA也有一系列指南作为GMP总则的附件，如Annex1 “无菌制剂”，Annex2 “生物制品”，Annex15 “验证和确认”，Annex1
10、8 “原料药GMP”。另外EMEA之下的CHMP也发布了一系列的指南。,国内外GMP法规和指南的异同点,指南会给出一些具体的标准 如：FDA的“Guidance for Industry, Sterile Drug Products Produced by Aseptic Processing- Current Good Manufacturing Practice , September 2004 “要求： HEPA过滤器完整性测试：泄漏率0.01% 层流罩空气流速：0.45 +/-20% (距离过滤器表面6 inches（15.2 cm)，并接近操作面） 各个洁净等级的颗粒浓度：100级（
11、3,520个/m3 at 0.5m) 10000级（352,000个/m3 at 0.5m） 各个洁净等级的微生物限度（以沉降菌为例）： 100级（1cfu, diam.90mm, 4hours) 10000级（5cfu, diam.90mm, 4hours),国内外GMP法规和指南的异同点,ISPE工程指南最具操作性 如厂房布局,墙板和地面材料, 空调系统标准, 换气次数,压差,温湿度, 制水设备, 水系统循环系统要求, 管道材料和抛光要求, 工程文件要求, 验证要求等等.,GOOD ENGINEERING PRACTICE,HVAC系统的要点,法规要求 以美国cGMP(21CFR Part
12、 210-211)为例 211.42(a) Any building or buildings used in the manufacture, processing, packing, or holding of a drug product shall be of suitable size, construction and location to facilitate cleaning, maintenance, and proper operations. 211.42(b) Any such building shall have adequate space for the or
13、derly placement of equipment and materials to prevent mixups between different components, drug product containers, closures, labeling, in-process materials, or drug products, and to prevent contamination. The flow of components, drug product containers, closures, labeling, in-process materials, and
14、 drug products through the building or buildings shall be designed to prevent contamination.,HVAC系统的要点,211.46(b) Equipment for adequate control over air pressure, micro-organisms, dust, humidity, and temperature shall be provided when appropriate for the manufacture, processing, packing, or holding
15、of a drug product. 211.46(c) Air filtration systems, including prefilters and particulate matter air filters, shall be used when appropriate on air supplies to production areas. If air is recirculated to production areas, measures shall be taken to control recirculation of dust from production. In a
16、reas where air contamination occurs during production, there shall be adequate exhaust systems or other systems adequate to control contaminants. 211.46(d) Air-handling systems for the manufacture, processing, and packing of penicillin shall be completely separate from those for other drug products for human use.,HVAC系统的要点 Key points,设计Design,施工 Construction,调试 Commissioning,验证 Qualification,URS,设计标准,施工文件,变更控制,设计文件控制,调试报告,URS,竣工资料,URS,验证报告,验证方案,全过程管理Whole Process Manageme
