FDA工艺验证指南新旧版透彻比较解读【整理者提醒】1-左侧文本为2011年1月最新修订版本,右侧文本为2008年11月草案版本。2-蓝色文本为修订后文本或者新增加文本。3-下划线文本是比旧版本增加的部分内容。4-删除线文本表示该部分存在于旧版本中,在新版本中删除。5-注释前面加【注释】2字注明。6-Zhulikou431关于FDA2008年11月草案彻底解读版本可以在丁香园论坛搜索到,欢迎下载阅读、讨论。7-不得用于商业用途,转载请注明丁香园信息。8-增加了新旧版本的中文译文。9-欢迎各位朋友提出宝贵建议,联系邮箱zhulikou431@126.com.GuidanceforIndustryProcessValidation:GeneralPrinciplesandPracticesFinalVersionJanuary2011Draft2008I.INTRODUCTION简介I.INTRODUCTIONThisguidanceoutlinesthegeneralprinciplesandapproachesthatFDAconsidersappropriateelementsofprocessvalidationforthemanufactureofhumanandanimaldrugandbiologicalproducts,includingactivepharmaceuticalingredients(APIsordrugsubstances),collectivelyreferredtointhisguidanceasdrugsorproducts.Thisguidanceincorporatesprinciplesandapproachesthatallmanufacturerscanusetovalidatemanufacturingprocesses.本指南概括了一般的原则与方法,这些原则与方法是FDA认为进行工艺验证的恰当要素,这些工艺被用于生产人用药、动物用药以及生物制品,包括活性药物成分(API或药用物质),在本指南中以上统称为药品或产品。本指南整合了一般的原则和方法,所有的生产企业都可以将这些原则和方法应用于生产工艺的验证。ThisguidanceoutlinesthegeneralprinciplesandapproachesthatFDAconsiderstobeappropriateelementsofprocessvalidationforthemanufactureofhumanandanimaldrugandbiologicalproducts,includingactivepharmaceuticalingredients(APIordrugsubstance),collectivelyreferredtointhisguidanceasdrugsorproducts.Thisguidanceincorporatesprinciplesandapproachesthatallmanufacturerscanuseinvalidatingamanufacturingprocess.本指南概括了一般的原则与方法,这些原则与方法是FDA认为进行工艺验证的恰当要素,这些工艺被用于生产人用药、动物用药以及生物制品,包括活性药物成分(API或药用物质),在本指南中以上统称为药品或产品。本指南整合了一般的原则和方法,所有的生产企业都可以将这些原则和方法应用于生产工艺的验证。ThisguidancealignsprocessvalidationactivitieswithaproductlifecycleconceptandwithexistingFDAguidance,includingtheFDA/InternationalConferenceonHarmonisation(ICH)guidancesforindustry,Q8(R2)PharmaceuticalDevelopment,Q9QualityRiskManagement,andQ10PharmaceuticalQualitySystem.2Althoughthisguidancedoesnotrepeattheconceptsandprinciplesexplainedinthoseguidances,FDAencouragestheuseofmodernpharmaceuticaldevelopmentconcepts,qualityriskman-agement,andqualitysystemsatallstagesofthemanufacturingprocesslifecycle.本指南将工艺验证活动与产品生命周期概念以及现有FDA相关指南进行了协调;这些存在的FDA指南包括FDA/ICH指南,Q8(R2)药品研发指南、Q9质量风险管理指南和Q10制药质量体系指南。尽管本指南没有重复上述指南解释的概念和ThisguidancealignsprocessvalidationactivitieswiththeproductlifecycleconceptandwithexistingFDAguidance.22SeetheFDA/InternationalConferenceonHarmonisation(ICH)guidancesforindustry:Q8PharmaceuticalDevelopment,Q9QualityRiskManagement,andwhenfinalized,Q10PharmaceuticalQualitySystem(anoticeofavailabilityfortheMay2007ICHdraftguidance,Q10PharmaceuticalQualitySystem,publishedintheFederalRegisteronJuly13,2007(72FR38604)).Weupdateguidancedocumentsperiodically.Tomakesureyouhavethemostrecentversionofaguidance,checktheCDERguidancepageat原则,FDA鼓励在药品制造工艺生命周期的各个阶段使用现代药品研发概念、质量风险管理和质量体系概念。注释2Tomakesureyouhavethemostrecentversionofaguidance,checktheCDERguidancepageat://://://://本指南将工艺验证活动与产品生命周期概念以及现有FDA相关指南(这里指得是Q8、Q9和Q10指南)进行了协调。Thelifecycleconceptlinksproductandprocessdevelopment,qualificationofthecommercialmanufacturingprocess,3andmaintenanceoftheprocessinastateofcontrolduringroutinecommercialproduction.Thisguidancesupportsprocessimprovementandinnovationthroughsoundscience.生命周期概念将产品与工艺开发、商业生产工艺的确认以及维护工艺在日常商业生产中处于受控状态连结在一起。本指南通过足够科学知识来支持工艺优化和革新。注释3Inthisguidance,thetermcommercialmanufacturingprocessreferstothemanufacturingprocessresultingincommercialproduct(i.e.,drugthatismarketed,distributed,andsoldorintendedtobesold).Forthepurposesofthisguidance,thetermcommercialmanufacturingprocessdoesnotincludeclinicaltrialortreatmentINDmaterial.Thelifecycleconceptlinksproductandprocessdevelopment,qualificationofthecommercialmanufacturingprocess,andmaintenanceoftheprocessinastateofcontrolduringroutinecommercialproduction.Thisguidancepromotesmodernmanufacturingprinciples,processimprovement,innovation,andsoundscience.生命周期概念将产品与工艺开发、商业生产工艺的确认以及维护工艺在日常商业生产中处于受控状态连结在一起。本指南可促进现代生产的原则、工艺改进、创新并且形成完善的科学。Thisguidancecoversthefollowingcategoriesofdrugs:Humandrugs Veterinarydrugs Biologicalandbiotechnologyproducts Finishedproductsandactivepharma ceuticalingredients(APIsordrugsubstances)4Thefollowingcategoriesofdrugsarewithinthescopeofthisguidance:Humandr ugsVeterinarydrugs Biologicalandbiotechnologyproducts Finishedproductsandactivepharmaceutical ingredients(APIordrugsubstance)3Thedrugconstituentofacombination (drugandmedicaldevice)product以下类别的药品在本指南范围之内:•人用药物•兽药•生物制品和生物技术产品•制剂产品与活性药物成分(API或药用物质)3•复合产品(药物和医疗设备)中的药物成分注释4Separatecurrentgoodmanufacturingpractice(CGMP)regulationsfordrugcomponentssuchasAPIs(drugsubstances)andintermediateshavenotpublishedasofthedateofthisguidance,butthesecomponentsaresubjecttothestat