who验证指南2016年版

1.INTRODUCTION简介1.1Validationisanessentialpartofgoodpracticesincludinggoodmanufacturingpractices(GMP)(4)andgoodclinicalpractices(GCP).Itisthereforeanelementofthepharmaceuticalqualitysystem.Validation,asaconcept,incorporatesqualificationandshouldbeappliedoverthelifecycleof,e.g.theapplicableproduct,process,system,equipmentorutility.验证是包括GMP和GCP在内的良好规范的必要部分。因此是制药质量体系的组成部分。验证这个概念包括确认并且应该在产品、工艺、系统、设备或设施的整个生命周期中被使用。1.2Theseguidelinescoverthegeneralprinciplesofvalidationandqualification.Inadditiontothemainpart,appendicesonvalidationandqualification(e.g.cleaning,computerandcomputerizedsystems,equipment,utilitiesandsystems,andanalyticalmethods)areincluded.这个指南包括验证和确认的一般原则。除了主体部分外，还包括确认和验证附件（如清洁、计算机和计算机化系统、设备、设施和系统以及分析方法）。1.3Thefollowingprinciplesapply:适用的原则如下:theexecutionofvalidationshouldbeincompliancewithregulatoryexpectations;验证的执行应该符合监管预期quality,safetyandefficacymustbedesignedandbuiltintotheproduct;质量、安全和效力应该被设计和构建到产品中qualitycannotbeinspectedortestedintotheproduct;质量不能通过检查或测试赋予产品qualityriskmanagementprinciplesshouldbeappliedindeterminingtheneed,scopeandextentofvalidation;应该应用质量风险管理规则来决定验证的需求、范围和程度ongoingreviewshouldtakeplacetoensurethatthevalidatedstateismaintainedandopportunitiesforcontinuingimprovementareidentified.应该进行持续的回顾来确保维持验证状态并识别持续改进的机会1.4Theimplementationofvalidationworkrequiresconsiderableresourcessuchas:验证工作的完成需要大量资源，例如time:generallyvalidationworkissubjecttorigoroustimeschedules;时间：一般验证工作需要有一个严密的时间表financial:validationoftenrequiresthetimeofspecializedpersonnelandexpensivetechnology.资金：验证经常需要专业人员和昂贵的技术human:validationrequiresthecollaborationofexpertsfromvariousdisciplines(e.g.amultidisciplinaryteam,comprisingqualityassurance,engineering,informationtechnology,manufacturingandotherdisciplines,asappropriate.).人员：验证需要不同学科专家的协作（例如一个多学科小组，视情况可能包括QA、工程、信息技术、生产以及其他学科人员）2.SCOPE范围2.1Theseguidelinesfocusmainlyontheoverallconceptofvalidationandarenotintendedtobeprescriptiveinspecificvalidationrequirements.Thisdocumentservesasgeneralguidanceonlyandtheprinciplesmaybeconsideredusefulinitsapplicationinthemanufactureandcontrolofstartingmaterialsandfinishedpharmaceuticalproducts(FPPs),aswellasotherareas.Validationofspecificprocessesandsystems,forexample,insterileproductmanufacture,requiresmuchmoreconsiderationandadetailedapproachthatisbeyondthescopeofthisdocument.这些指南主要关注验证的整体概念，无意规定具体的验证要求。用作GMP检查官和生产商的基本指南，本文件仅作为一个一般指南，其原则在其应用于起始物料及制剂的生产和控制时会比较有用，也应用于其他领域。特定工艺和产品的验证，例如无菌产品生产，需要考虑更多内容，和更详细的方法，不在本文件范围之内。2.2Therearemanyfactorsaffectingthedifferenttypesofvalidationanditis,therefore,notintendedtodefineandaddressallaspectsrelatedtooneparticulartypeofvalidationhere.有很多因素会对不同类型的验证产生影响，因此，这里不会对某个特定类型的验证相关的所有方面进行定义和说明。2.3Thegeneraltextinthemainpartoftheseguidelinesmaybeapplicabletovalidationandqualificationofpremises,equipment,utilities,systems,processesandprocedures.这些指南的主体部分的一般内容可能适用于设施、设备、公用设施和系统、工艺和程序的验证和确认。3.GLOSSARY术语Thedefinitionsgivenbelowapplytothetermsusedintheseguidelines.Theymayhavedifferentmeaningsinothercontexts.本指南使用的术语定义如下。它们在其它环境中可能有不同的含义calibration.Thesetofoperationsthatestablish,underspecifiedconditions,therelationshipbetweenvaluesindicatedbyaninstrumentorsystemformeasuring(forexample,weight,temperatureandpH),recording,andcontrolling,orthevaluesrepresentedbyamaterialmeasure,andthecorrespondingknownvaluesofareferencestandard.Limitsforacceptanceoftheresultsofmeasuringshouldbeestablished.校准：changecontrol(includingchangemanagement).Aformalsystembywhichqualifiedrepresentativesofappropriatedisciplinesreviewproposedoractualchangesthatmightaffectavalidatedstatus.Theintentistodeterminetheneedforactionthatwouldensurethatthesystemismaintainedinavalidatedstate(referenceworkingdocumentQAS/15.639/Rev.1-unpublished).变更控制（包括变更管理）cleaningvalidation.Documentedevidencetoestablishthatcleaningproceduresareremovingresiduestopredeterminedlevelsofacceptability,takingintoconsiderationfactorssuchasbatchsize,dosing,toxicologyandequipmentsize.清洁验证commissioning.Thesettingup,adjustmentandtestingofequipmentorasystemtoensurethatitmeetsalltherequirements,asspecifiedintheuserrequirementspecification,andcapacitiesasspecifiedbythedesignerordeveloper.Commissioningiscarriedoutbeforequalificationandvalidation.试车computervalidation(includingcomputerizedsystemvalidation).Confirmationbyexaminationandprovisionofobjectivedocumentedevidencethatcomputerizedsystemspecificationsconformtouserneedsandintendeduses,andthatallrequirementscanbeconsistentlyfulfilled.计算机验证（包括计算机化系统验证）concurrentvalidation.Validationcarriedoutduringroutineproductionofproductsintendedforsale.同步验证designqualification.Documentedverificationthattheproposeddesignoffacilities,systemsandequipmentissuitablefortheintendedpurpose.设计确认goodengineeringpractices.Establishedengineeringmethodsandstandardsthatareappliedthroughouttheprojectlife-cycletodeliverappropriate,cost-effectivesolutions.良好工程规范installationqualification.Documentedverificationthattheinstallations(suchasmachines,computersystemcomponents,measuringdevices,utilitiesandmanufacturingareas)usedinaprocessorsystemareappropriatelyselectedand