ISPE Critical Utilities GMP Compliance-关键设施的GMP符合性-2020.pdf

GOODPRACTICEGUIDE:

CriticalUtilities

GMPCompliance

HowtoBeCompliantand

ReadytoProveIt

Disclaimer:

ThisGoodPracticeGuideisintendedtoprovideguidanceonachievingandmaintainingcriticalutilitysystems

compliance,andtobeanaidtoorganizationsinpreparingandhostingregulatoryinspectionsandaudits.ThisGuide

issolelycreatedandownedbyISPE.Itisnotaregulation,standardorregulatoryguidelinedocument.ISPEcannot

ensureanddoesnotwarrantthatasystemmanagedinaccordancewiththisGuidewillbeacceptabletoregulatory

authorities.Further,thisGuidedoesnotreplacetheneedforhiringprofessionalengineersortechnicians.

LimitationofLiability

InnoeventshallISPEoranyofitsaffiliates,ortheofficers,directors,employees,members,oragentsofeachof

them,ortheauthors,beliableforanydamagesofanykind,includingwithoutlimitationanyspecial,incidental,

indirect,orconsequentialdamages,whetherornotadvisedofthepossibilityofsuchdamages,andonanytheoryof

liabilitywhatsoever,arisingoutoforinconnectionwiththeuseofthisinformation.

©CopyrightISPE2020.Allrightsreserved.

Allrightsreserved.Nopartofthisdocumentmaybereproducedorcopiedinanyformorbyanymeans–graphic,

electronic,ormechanical,includingphotocopying,taping,orinformationstorageandretrievalsystems–without

writtenpermissionofISPE.

Alltrademarksusedareacknowledged.

ISBN978-1-946964-29-8

Page2ISPEGoodPracticeGuide: