who验证指南Word格式文档下载.docx

who验证指南Word格式文档下载.docx

《who验证指南Word格式文档下载.docx》由会员分享，可在线阅读，更多相关《who验证指南Word格式文档下载.docx（46页珍藏版）》请在冰豆网上搜索。

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）:

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

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