FDA最新工艺验证指南1版中文版文档格式.docx
《FDA最新工艺验证指南1版中文版文档格式.docx》由会员分享，可在线阅读，更多相关《FDA最新工艺验证指南1版中文版文档格式.docx（75页珍藏版）》请在冰点文库上搜索。
CurrentGoodManufacturingPractices（CGMP）
Revision1
美国卫生与人类服务部
食品药品管理局
药物评价和研究中心（CDER）
生物制品评价和研究中心（CBER）
兽药中心（CVM）
2011年1月
现行药品质量生产管理规范（CGMP）
修订版1
包含不具约束力的建议
中文译稿：
北京大学药物信息与工程研究中心**************
Additionalcopiesareavailablefrom:
OfficeofCommunications
DivisionofDrugInformation,WO51,Room2201
10903NewHampshireAve.
SilverSpring,MD20993
Phone:
301-796-3400;
Fax:
301-847-8714
****************.gov
www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm
and/or
OfficeofCommunication,OutreachandDevelopment,HFM-40
CenterforBiologicsEvaluationandResearch
1401RockvillePike,Rockville,MD20852-1448
（Tel）800-835-4709or301-827-1800
www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm
CommunicationsStaff,HFV-12
CenterforVeterinaryMedicine
7519StandishPlace,
Rockville,MD20855
（Tel）240-276-9300
www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm
另外的副本可从以下部门得到：
马里兰州银泉市新罕布什尔大道10193号2201室药品信息处，对外信息办公室，
邮政编码：
20993
电话：
301-796-3400;
传真：
301-847-8714
和/或
马里兰州洛克维尔市洛克维尔大道1401号HFM-40FDA生物制品评价和研究中心对外信息、外联
与发展办公室邮政编码：
20852-1448
800-835-4709或301-827-1800
马里兰州洛克维尔市StandishPlace7519号食品药品管理局兽药中心HFV-12通讯处，邮政编码：
20885
240-276-9300
药物评估和研究中心（CDER）
生物制品评估和研究中心（CBER）
TableofContents
I.INTRODUCTION........................................................................................................................................1
一.简介..........................................................................................................................................................1
II.BACKGROUND.........................................................................................................................................3
二.背景..........................................................................................................................................................3
A.ProcessValidationandDrugQuality..................................................................................................4
A.工艺验证与药品质量....................................................................................................................4
B.ApproachtoProcessValidation.........................................................................................................5
B.工艺验证方法................................................................................................................................5
III.STATUTORYANDREGULATORYREQUIREMENTSFORPROCESSVALIDATION...............................7
三.对工艺验证的法规和监管要求...........................................................................................................7
IV.RECOMMENDATIONS...............................................................................................................................9
四.建议..........................................................................................................................................................9
A.GeneralConsiderationsforProcessValidation..................................................................................9
A.对工艺验证的总体考虑...............................................................................................................9
B.Stage1-ProcessDesign.................................................................................................................10
B.第一阶段-工艺设计.................................................................................................................10
1.BuildingandCapturingProcessKnowledgeandUnderstanding............................................11
1.建立和捕获工艺知识与理解............................................................................................11
2.EstablishingaStrategyforProcessControl............................................................................12
2.建立工艺控制策略.............................................................................................................12
C.Stage2-ProcessQualification........................................................................................................14
C.第二阶段-工艺确认.................................................................................................................14
1.DesignofaFacilityandQualificationofUtilitiesandEquipment.............................................14
1.厂房设施设计以及公用设施与设备确认......................................................................14
2.ProcessPerformanceQualification.........................................................................................16
2.工艺性能确认......................................................................................................................16
3.PPQProtocol...........................................................................................................................17
3.工艺性能确认方案.............................................................................................................17
4.PPQProtocolExecutionandReport.......................................................................................19
4.工艺性能确认执行与报告................................................................................................19
D.Stage3-ContinuedProcessVerification.........................................................................................20
D.第三阶段-持续工艺验证........................................................................................................20
V.CONCURRENTRELEASEOFPPQBATCHES.......................................................................................22
五.工艺性能确认批次的同时放行.........................................................................................................22
VI.DOCUMENTATION..................................................................................................................................24
六.文件记录................................................................................................................................................24
VII.ANALYTICALMETHODOLOGY...............................................................................................................24
七.分析方法................................................................................................................................................24
GLOSSARY...................................................................................................................................................26
术语表..........................................................................................................................................................26
REFERENCES...............................................................................................................................................28
参考资料......................................................................................................................................................28
1
GuidanceforIndustry1
行业指南1
GeneralPrinciplesandPractices
一般原则与实施
ThisguidancerepresentstheFoodandDrugAdministration’s（FDA’s）currentthinkingonthistopic.Itdoes
notcreateorconferanyrightsfororonanypersonanddoesnotoperatetobindFDAorthepublic.Youcan
useanalternativeapproachiftheapproachsatisfiestherequirementsoftheapplicablestatutesand
regulations.Ifyouwanttodiscussanalternativeapproach,contacttheFDAstaffresponsiblefor
implementingthisguidance.IfyoucannotidentifytheappropriateFDAstaff,calltheappropriatenumber
listedonthetitlepageofthisguidance.
本指南体现了食品药品管理局（FDA）关于这一主题的最新见解。
本指南不为任何人或
对任何人才创造或赋予任何权利，不起束缚FDA或公众的作用。
如果替代方法能够满足适
用法律、法规的要求，您可以使用替代方法。
如果您希望讨论一种替代性方法，请与负责执
行本指南的FDA工作人员联系。
如果您不能确定相应的FDA工作人员，请拨打本指南标题
页所列的相应电话号码。
I.INTRODUCTION
一.简介
ThisguidanceoutlinesthegeneralprinciplesandapproachesthatFDAconsidersappropriateelementsof
processvalidationforthemanufactureofhumanandanimaldrugandbiologicalproducts,includingactive
pharmaceuticalingredients（APIsordrugsubstances）,collectivelyreferredtointhisguidanceasdrugsor
products.Thisguidanceincorporatesprinciplesandapproachesthatallmanufacturerscanusetovalidate
manufacturingprocesses.
本指南概述了FDA认为是包括原料药在内的人与动物用药和生物制品（在本指南中合称为
药品或制品）生产工艺验证相应要素的一般原则和方法。
该指南收编了所有生产商可用于验
证生产工艺的多种原则和方法。
Thisguidancealignsprocessvalidatio
升级会员 