who验证指南.docx

who验证指南.docx

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who验证指南

WorkingdocumentQS/03.055/Rev.1RESTRICTED

WORLDHEALTHORGANIZATIONORGANISATIONMONDIALEDELASANTE

SUPPLEMENTARYGUIDELINESON

GOODMANUFACTURINGPRACTICES（GMP）:

VALIDATION

©WorldHealthOrganization2003

Allrightsreserved.

Thisdraftisintendedforarestrictedaudienceonly,i.e.theindividualsandorganizationshavingreceivedthisdraft.Thedraftmaynotbereviewed,abstracted,quoted,reproduced,transmitted,distributed,translatedor

adapted,inpartorinwhole,inanyformorbyanymeansoutsidetheseindividualsandorganizations（includingtheorganizations’concernedstaffandmemberorganizations）withoutthepermissionofWHO.Thedraftshouldnotbedisplayedonanywebsite.

Pleasesendanyrequestforpermissionto:

DrSabineKopp,QualityAssurance&Safety:

Medicines（QSM）,DepartmentofEssentialDrugsandMedicinesPolicy（EDM）,WorldHealthOrganization,CH-1211Geneva27,Switzerland.

Fax:

（41-22）7914730;e-mails:

ThedesignationsemployedandthepresentationofthematerialinthisdraftdonotimplytheexpressionofanyopinionwhatsoeveronthepartoftheWorldHealthOrganizationconcerningthelegalstatusofanycountry,

territory,cityorareaorofitsauthorities,orconcerningthedelimitationofitsfrontiersorboundaries.Dottedlinesonmapsrepresentapproximateborderlinesforwhichtheremaynotyetbefullagreement.

Thementionofspecificcompaniesorofcertainmanufacturers’productsdoesnotimplythattheyareendorsedorrecommendedbytheWorldHealthOrganizationinpreferencetoothersofasimilarnaturethatarenotmentioned.Errorsandomissionsexcepted,thenamesofproprietaryproductsaredistinguishedbyinitialcapitalletters.

TheWorldHealthOrganizationdoesnotwarrantthattheinformationcontainedinthisdraftiscompleteandcorrectandshallnotbeliableforanydamagesincurredasaresultofitsuse.

WorkingdocumentQS/03.055/Rev.1

page2

TENTATIVESCHEDULEFORTHEADOPTIONPROCESSOFDOCUMENTQAS/03.055:

SUPPLEMENTARYGUIDELINESONGMP:

VALIDATION

WorkingdocumentQS/03.055/Rev.1page3

SUPPLEMENTARYGUIDELINESONGOODMANUFACTURINGPRACTICES

（GMP）:

VALIDATION

CONTENTS

1.Introduction

2.Glossary

3.Scopeofdocument

4.Validation

4.1Approachestovalidation

4.2Scopeofvalidation

4.3Benefitsofvalidation

5.Qualification

6.Calibrationandverification

7.Validationteam

8.ValidationMasterPlan（VMP）

8.1Generalrequirements

8.2Specificrequirements

9.ValidationProtocol（VP）

10.ValidationReport（VR）

11.Relationshipbetweenvalidationandqualification

11.1Premises

11.2Systems

11.2.1Heating,VentilationandAirConditioning

System（HVAC）

11.2.2Watersystem

11.3Equipment

11.4Processes

11.5Procedures

11.5.1Analyticalmethod

11.5.2Packagingcomponent

11.5.3Cleaningvalidation

11.6Computersystemsvalidation

12.QualificationstagesPage56888810101011121212131414141516161717171718181819

WorkingdocumentQS/03.055/Rev.1

page4

12.1DesignQualification（DQ）12.2InstallationQualification（IQ）12.3OperationalQualification（OQ）12.4PerformanceQualification（PQ）12.5Re-qualification12.6Qualificationreport

13.Processvalidation

13.1Prospectivevalidation13.2Concurrentvalidation13.3Retrospectivevalidation

14.Computervalidation

14.1General14.2Systemspecification14.3Functionalspecification14.4Security14.5Back-ups14.6Validation14.7Validationofhardwareandsoftware

14.7.1Hardware

14.7.2Software

15.Analyticalvalidation

15.1General15.2Pharmacopoeiamethods15.3Non-pharmacopoeiamethods15.4Methodvalidation15.5Validationreport15.6Characteristicsofanalyticalprocedures

16.Cleaningvalidation

16.1General16.2Sampling16.3Analyticalmethods16.4Evaluation

17.Re-validation

17.1Periodicre-validation17.2Re-validationafterchanges

18.Changecontrol

19.Personnel19192020212121212223242424252626262627282929292930303033333537414243434444

ReferencesWorkingdocumentQS/03.055/Rev.1page546

47Annex:

FormatforanInstallationQualificationProtocolandReport

1.INTRODUCTION

ValidationisanessentialandintegralpartofGoodManufacturingPractice（GMP）.

Itis,therefore,anelementofthequalityassuranceprogrammeassociatedwithaparticularproductorprocess.Itisacceptedthatthebasicprinciplesofqualityassurancehaveastheirgoaltheproductionofproductsthatarefitfortheirintendeduse.Theseprinciplesmaybestatedas:

（1）quality,safetyandefficacymustbedesignedandbuiltintotheproduct;

（2）qualitycannotbeinspectedortestedintothefinishedproduct;and

（3）eachstepofthemanufacturingprocessmustbecontrolledtomaximizethe

probabilitythatthefinishedproductmeetsallqualityanddesignspecifications.

Validationofprocessesandsystemsisfundamenta