WHO TRS1019 附录 3-GMP 验证指南，附录 5，计算机化系统的验证，2019.pdfVIP

Annex3

Goodmanufacturingpractices:guidelinesonvalidation

Background

TheneedforrevisionofthepublishedWorldHealthOrganization(WHO)

Supplementaryguidelinesongoodmanufacturingpractices:validation(1)was

identifiedbythePrequalificationofMedicinesProgrammeandafirstdraft

documentwascirculatedforcommentinearly2013.Thefocus,atthattime,was

revisionoftheappendixonNon-sterileprocessvalidation(Appendix7)(2),which

hadbeenrevisedandwasadoptedbytheECSPPatitsForty-ninthmeetingin

October2014(3).

Theoverarchingtextpresentedinthisannexconstitutesthegeneral

principlesofthenewguidanceonvalidation.

Thefollowingappendicesincludedinthisannexaddressspecificaspects

ofvalidationandareintendedtocomplementthegeneraltextonvalidation:

■Appendix1.Validationofheating,ventilationandair-conditioning

systems(ascross-referencetoTRS1010,Annex8(4))

■Appendix2.Validationofwatersystemsforpharmaceuticaluse

(aspublishedinTRS937,Annex4,2006andascross-referenceto

TRS970,Annex2,2012(5)

■Appendix3.Cleaningvalidation(aspublishedinTRSandTRS937,

Annex4,2006andascross-referencetoTRS970,Annex2,2012(5)

■Appendix4.Analyticalprocedurevalidation(adopted,subjectto

areviewofthecommentsreceivedbyasubgroupoftheExpert

Committee)

■Appendix5.Validationofcomputerizedsystems(adopted,subject

tothechangesdiscussedbytheExpertCommittee)

■Appendix6.Guidelinesonqualification(adopted,subjecttoareview

ofthecommentsreceivedbyasubgroupoftheExpertCommittee)

■Appendix7.Non-sterileprocessvalidation(aspublishedinTRS992,

Annex3,2015(3)).