FDA清洁验证指南(中英文对照).pdf

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1、ValidationofCleaningProcesses清洁工艺验证GUIDETOINSPECTIONSVALIDATIONOFCLEANINGPROCESSES清洁工艺验证检查指南MikeMaSortoutXiaoGangNote:ThisdocumentisreferencematerialforinvestigatorsandotherFDApersonnel.ThedocumentdoesnotbindFDA,anddoesnoconferanyrights,privileges,benefits,orimmunitiesfororonanyper

2、son(s).注意：本指南是审计官和其他FDA人员的参考资料。FDA不受本指南的约束，也没有授予任何人任何权利、特权、收益或豁免权。1of14ContentI.INTRODUCTION简介...............................................................................................................................................3II.BACKGROUND背景.............................

3、...................................................................................................................3III.GENERALREQUIREMENTS常规要求....................................................................................................................5IV.EVALUATIONOFCLEANIN

4、GVALIDATION清洁验证的评估..................................................................................6V.ESTABLISHMENTOFLIMITS确定限度.................................................................................................................11VI.OTHERISSUES其他问题.....................

5、................................................................................................................12VII.REFERENCES参考资料.......................................................................................................................................132of14I.INTROD

6、UCTION简介Validationofcleaningprocedureshasgeneratedconsiderablediscussionsinceagencydocuments,includingtheInspectionGuideforBulkPharmaceuticalChemicalsandtheBiotechnologyInspectionGuide,havebrieflyaddressedthisissue.TheseAgencydocumentsclearlyestablishtheexpectationthatcleaningproce

7、dures(processes)bevalidated.自从机构文件，包括化学原料药制剂检查指南和生物技术制剂检查指南简明的提及清洁验证规程以来，就对清洁规程验证产生了大量的讨论。这些机构的文件明确建立了清洁规程验证的预期结果。Thisguideisdesignedtoestablishinspectionconsistencyanduniformitybydiscussingpracticesthathavebeenfoundacceptable(orunacceptable).Simultaneously,onemustrecognizethatforc

8、leaningvalidation,aswithva