ISPE GPG：生命周期方法ISPE-Good Practice Guide_Practical Implementa.pdf

ISPE

GOODPRACTICEGUIDE:

Practicalementation

oftheLifecycleApproach

toProcessValidation

aceuticalDeveloprhe

ProcessQualificatio

Validatio

ontinued/Ongoirq

recessVerificati

anufacturi

HistoricalStatisticaIDetll

ISPE

GOODPRACTICEGUIDE:

PracticalImplementation

oftheLifecycleApproach

toProcessValidation

Disclaimer:

ThisISPEGoodPracticeGuide:PracticalImplementationoftheLifecycleApproachtoProcessValidationprovides

detailedpracticalguidancetohelppharmaceuticalcompaniesmeetglobalregulatoryprocessvalidationexpectations.

ThisGuideissolelycreatedandownedbyISPE.Itisnotaregulation,standardorregulatoryguidelinedocument.

ISPEcannotensureanddoesnotwarrantthatasystemmanagedinaccordancewiththisGuidewillbeacceptableto

regulatoryauthorities.Further,thisGuidedoesnotreplacetheneedforhiringprofessionalengineersortechnicians.

LimitationofLiabifity

InnoeventshallfSPEoranyofitsatliliates,ortheoliicers,directors,employees,members,oragentsofeach

ofthem,ortheauthors,befiabfeforanydamagesofanykind,includingwithoutlimitationanyspecial,incidenfaf,

indirect,orconsequentialdamages,whetherornotadvisedofthepossibilityofsuchdamages,andonanytheoryof

liabilit