冻干技术：德国MARTIN CHRIST的刘树强所演讲冻干技术 第四册.pdf

cGMP / FDA – Regulations - MostMost relevantrelevant guidelinesguidelines –相关法规相关法规 Japan 日本GMPs US美国cGMPs EU 欧盟GMPs Local 当地GMPs GMP regulations = basis of qualification, no specific requirements GMP规定=验证的基础，没有特异性的要求 Guidelines describe practices and implementation 在实际工作中遵从的指导原则在实际工作中遵从的指导原则 e.g. USA美国 e.g. EU欧盟 FDA: Guidance for Industryy: EU-GMP: General guide for Sterile Drug Products produced pharmaceuticals, by Aseptic Processing e.g. Annex 15 Qualification and CFRCFR (Code(Code ofof FederalFederal Validation Regulation) EN ISO, e.g. - 21CFR210 and 211 - 13408 Aseptic processing -- 2121CFRCFR1111 (part(part 33 Lyophilization,Lyophilization, partpart 55 Sterilization)Sterilization) - 14644 Containment/Isolators cGMP / FDA – Regulations -- MostMost relevantrelevant guidelinesguidelines --相关法规相关法规 “Older” Proposals are described in the monographs of thethe ParenteralParenteral SocietySociety – butbut stillstill used:used: 过去在非肠道学会相关专著中的描述，目前仍在使用 No. 5: Sterilisation of freeze dryers 冻干机灭菌 No.No. 7:7: LeakLeak testingtesting ofof freezefreeze dryersdryers冻干机检漏冻干机检漏 No. 8: Integrity testing of freeze dryers完整性实验 NoNo. 99: SpecificationSpecification andand validationalidation ofof freefreezee drdryersers 冻干机技术指标和认证 No. 10: Introduction to pharmaceutical freeze dryers 制药冻干机介绍 Included in our design are also the FDA Inspection Guides – Lyyopphilisation of Parenterals 包含在我们的设计中，也是FDA的考核指导 What does Validation apply to? 验验证的应用范围的应用范围？ SSysttem QQualifilificatition – DDefifinitiition 系统验证系统验证--定义定义 According to FDA equipment qualification is: 美国FDA的定义 „Es