PIC+最新无菌指南

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1、PHARMACEUTICALINSPECTIONCONVENTIONPHARMACEUTICALINSPECTIONCO-OPERATIONSCHEMEPI007-47February2009RECOMMENDATIONONTHEVALIDATIONOFASEPTICPROCESSES©PIC/SJanuary2009Reproductionprohibitedforcommercialpurposes.Reproductionforinternaluseisauthorised,providedthatthesourceisacknowledge

2、d.Editor:PIC/SSecretariate-mail:info@picscheme.orgwebsite:http://www.picscheme.orgPI007-47February2009TABLEOFCONTENTSPage1.DOCUMENTHISTORY..............................................................................12.INTRODUCTION..............................................

3、..........................................12.1Purpose......................................................................................................12.2Scope.........................................................................................................12.3Gene

4、ralinformation....................................................................................13.DEFINITIONS.............................................................................................24.PROCESSSIMULATIONTESTPROCEDURES......................................

5、.44.1GeneralComments....................................................................................44.2LiquidProducts...........................................................................................44.3InjectablePowderProducts....................................

6、....................................54.4SuspensionProducts..................................................................................54.5FreezeDried(Lyophilised)Products...........................................................54.6Semi-SolidProducts(e.g.sterileointment

7、s)...............................................64.7ClinicalTrialsMaterialsandSmallBatchSizeProducts.............................64.8BiologicalandBiotechnologyProducts.......................................................64.9SterileBulkPharmaceuticals........................

8、..............................................65.PROCESSSIMUL