ISPE APQ Corrective Action And Preventive Action (CAPA) System 完整版超高清.pdfVIP

Forindividualuseonly.©CopyrightISPE2020.Allrightsreserved.

GUIDE:

CorrectiveActionand

PreventiveAction

(CAPA)System

Disclaimer:

TheISPEAPQGuideSeriesprovidesapracticalqualitymanagementframeworkthatpharmaceuticalorganizations

canusetoassessandadvancetheeffectivenessofPharmaceuticalQualitySystemelements.ThisGuideis

solelycreatedandownedbyISPE.Itisnotaregulation,standardorregulatoryguidelinedocument.ISPEcannot

ensureanddoesnotwarrantthatasystemmanagedinaccordancewiththisGuidewillbeacceptabletoregulatory

authorities.Further,thisGuidedoesnotreplacetheneedforhiringprofessionalengineersortechnicians.

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ISBN978-1-946964-36-6

Forindividualuseonly.©CopyrightISPE2020.Allrightsreserved.

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