洁净空调系统确认.ppt

洁净空调系统验证ValidationofHVACSystem-Macroprocess-主题国内外有关法规和指南RegulationandGuidanceHVAC系统的要点KeypointsofHVACsystem验证内容QualificationContent法规和指南RegulationandGuidance(SFDA)GoodManufacturingPractice,revisedin1998(SFDA),,.欧盟药品法规第4卷GMP(人用和兽用药品)Annex1totheEUGuidetoGoodManufacturingPractice,.欧盟GMP的附录1-无菌药品的生产,2003版Annex15totheEUGuidetoGoodManufacturingPractice“ValidationandQualification”欧盟GMP的附录15-验证和确认法规和指南RegulationandGuidance(FDA)Title21,CodeofFederalRegulations,Part210,CurrentGoodManufacturingPracticeinManufacturing,Processing,Packing,orHoldingofDrugs;General.(FDA)联邦法规第21篇第210部分,有关药品生产、加工、包装和贮存的CGMP总则(FDA)Title21,CodeofFederalRegulations,Part211,CurrentGoodManufacturingPracticeforFinishedPharmaceuticals.(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)Title21,CodeofFederalRegulations,Part11,ElectronicRecords;ElectronicSignature.(FDA)联邦法规第21篇第11部分,电子记录和电子签名(FDA)GuidelineonSterileDrugProductsProducedbyAsepticProcessing,September2004(FDA)无菌工艺的无菌药品生产的指南,2004年9月法规和指南RegulationandGuidanceISPEPharmaceuticalEngineeringGuides:ISPE制药工程指南:Volume1:BulkPharmaceuticalChemicalFacilities卷一:化学原料药厂房Volume2:OralSolidDosageForms卷二:口服固体制剂Volume3:SterileManufacturingFacilities卷三:missioningandQualification卷五:调试和确认Volume6:Biopharmaceutics卷六:生物制药法规和指南RegulationandGuidanceISO14644CleanRoomStandardISO14644洁净室标准Part1:Classificationofaircleanliness第一部份:空气洁净度分类Part2:Specificationsfortestingandmonitoring第二部分:测试和监视的标准Part3:TestMethods第三部分:测试方法Part4:Design,ConstructionandStart-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:FDAcGMP(b)ponents,drugproductcontainers,closures,labeling,in-processmaterials,ordrugproducts,andtopreventcontamination.,processing,packing,orholdingofadrugproductshallbeofappropriatedesign,adequatesize,andsuitablylocatedtofacilitateoperationsforitsintendeduseandf