who验证指南版.docx
- 文档编号:27625134
- 上传时间:2023-07-03
- 格式:DOCX
- 页数:24
- 大小:71.58KB
who验证指南版.docx
《who验证指南版.docx》由会员分享,可在线阅读,更多相关《who验证指南版.docx(24页珍藏版)》请在冰豆网上搜索。
who验证指南版
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).Aformalsystembywhichqualifiedrepresentativesofappropriatedisciplinesreviewproposedoractual
工艺验证
prospectivevalidation.Validationcarriedoutduringthedevelopmentstageonthebasisofariskanalysisoftheproductionprocess,whichisbrokendownintoindividualsteps;thesearethenevaluatedonthebasisofpastexperiencetodeterminewhethertheymayleadtocriticalsituations.
前验证
qualification.Documentedevidencethatpremises,systemsorequipmentareabletoachievethepredeterminedspecificationsproperlyinstalled,and/orworkcorrectlyandleadtotheexpectedresults.Qualificationisoftenapart(theinitialstage)ofvalidation,buttheindividualqualificationstepsalonedonotconstituteprocessvalidation.
确认
revalidation.Repeatedvalidationofapreviouslyvalidatedsystem(orapartthereof)toensurecontinuedcompliancewithestablishedrequirements.
再验证:
对先前已验证的系统(或它的一部分)的重复验证来确保持续符合既定标准。
standardoperatingprocedure.Anauthorizedwrittenproceduregivinginstructionsforperformingoperationsnotnecessarilyspecifictoagivenproductormaterialbutofamoregeneralnature(e.g.equipmentoperation,maintenanceandcleaning;validation;cleaningofpremisesandenvironmentalcontrol;samplingandinspection).Certainstandardoperatingproceduresmaybeusedtosupplementproduct-specificmasterbatchproductiondocumentation.
标准操作规程
validation.Actionofprovinganddocumentingthatanyprocess,procedureormethodactuallyandconsistentlyleadstotheexpectedresults.
验证
validationmasterplan.Thevalidationmasterplanisahigh-leveldocumentthatestablishesanumbrellavalidationplanfortheentireprojectandsummarizesthemanufacturer’soverallphilosophyandapproach,tobeusedforestablishingperformanceadequacy.Itprovidesinformationonthemanufacturer’svalidationworkprogrammeanddefinesdetailsofandtimescalesforthevalidationworktobeperformed,includingastatementoftheresponsibilitiesofthoseimplementingtheplan.
验证主计划
validationprotocol.Adocumentdescribingtheactivitiestobeperformedduringavalidation,includingtheacceptancecriteriafortheapprovalofaprocessorsystem–orapartthereof–forintendeduse.
验证方案
validationreport.Adocumentinwhichtherecords,resultsandevaluationofvalidationareassembledandsummarized.Itmayalsocontainproposalsfortheimprovementofprocessesand/orsystemsand/orequipment.
验证报告
verification.Theapplicationofmethods,procedures,testsandotherevaluations,inadditiontomonitoring,todeterminecompliancewithestablishedrequirementsandspecifications.
核实
worstcase.Aconditionorsetofconditionsencompassingtheupperandlowerprocessinglimitsforoperatingparametersandcircumstances,withinSOPs,whichposethegreatestchanceofproductorprocessfailurewhencomparedtoidealconditions.Suchconditionsdonotnecessarilyincludeproductorprocessfailure.
最差条件
4.RELATIONSHIPBETWEENVALIDATIONANDQUALIFICATION
验证与确认的关系
4.1Qualificationandvalidationareessentiallythesame.Thetermqualificationisnormallyusedforequipmentandutilities,andvalidationforsystemsandprocesses.Inthissense,qualificationcanbeseenaspartofvalidation.
确认和验证本质上是一样的。
确认通常用于设备和设施,而验证则用于系统和工艺。
在这层意义上,确认可以被看做是验证的一部分。
4.2Wheretheterm“validation”isusedinthedocument,thesameprinciplesmaybeapplicablefor“qualification
在文件中使用术语“验证”的规则同样适用于“确认”
5.VALIDATION
验证
Approachestovalidation
验证的方法
5.1Manufacturersshouldorganizeandplanvalidationinamannerthatwillensureproductquality,safetyandefficacythroughoutitslifecycle.
生产商应该组织和计划验证以保证产品在其生命周期内的质量、安全和有效。
5.2Thescopeandextentofqualificationandvalidationshouldbebasedonriskmanagementprinciples.
确认和验证的范围和程度应该基于风险管理规则。
5.3Statisticalcalculationsshouldbeapplied,whereappropriate,andprovidescientificevidencethattheprocess,systemorotherrelatedaspectisappropriatelyvalidated.
适当时,应该使用统计学计算并提供工艺、系统或其它相关方面有效的科学证据
5.4Qualificationandvalidationshouldbedoneinaccordancewithpredeterminedprotocols,andtheresultsappropriatelydocumented,e.g.inreports.
确认和验证应该按照预定的方案执行并且结果应被适当的记录,如在报告中。
5.5Thereshouldbeanappropriateandeffectivequalitysystemensuringtheorganizationandmanagementofvalidation.
应有适当的和有效的质量体系来保证验证的组织和管理。
5.6Seniormanagementshouldensurethattherearesufficientresourcestoperformvalidationinatimelymanner.Managementandpersonsresponsibleforqualityassuranceshouldbeactivelyinvolvedintheprocessandauthorizationofprotocolsandreports.
高级管理层应该确保充分的资源来及时地执行验证。
管理层和质量保证负责人应该积极参与方案和报告的批准活动中。
5.7Personnelwithappropriatequalificationandexperienceshouldberesponsibleforperformingvalidation.
有适当资质和经验的人员应该对验证的执行负责。
5.8Thereshouldbeaspecificprogrammeorscheduletosupportplanningandexecutionofvalidationactivities.
应有专门的计划或时间表来支持计划和执行验证活动。
5.9Validationshouldbeperformedinastructuredwayaccordingtothedocumentedprotocolsandprocedures.
验证应该按照文件化的方案和规程以一种有组织的方式执行。
5.10Qualificationandvalidationshouldbeperformed:
确认和验证应该被执行:
‒fornewpremises,equipment,utilitiesandsystems,andprocessesandprocedures;
新设施、设备、公用设施和系统,以及新的工艺和程序;
‒whenchangesaremade,dependingontheoutcomeofriskassessment;
当发生变更时,根据风险评估的结果;
‒wherenecessaryorindicatedbasedontheoutcomeofperiodicreview.
基于定期回顾的结果表明需要的
5.11Awrittenreportontheoutcomeofthevalidationshouldbeprepared.
应该对验证的结果准备一份书面报告。
5.12Thescopeandextentofvalidationshouldbebasedonknowledgeandexperience,andtheoutcomeofqualityriskmanagementprinciplesasdescribedintheWorldHealthOrganization(WHO)guidelinesonqualityriskmanagement.Wherenecessaryworst-casesituationsorspecificchallengetestsshouldbeconsideredforinclusioninthevalidation,forexample,stressloadandvolumeverificationincomputersyst
- 配套讲稿:
如PPT文件的首页显示word图标,表示该PPT已包含配套word讲稿。双击word图标可打开word文档。
- 特殊限制:
部分文档作品中含有的国旗、国徽等图片,仅作为作品整体效果示例展示,禁止商用。设计者仅对作品中独创性部分享有著作权。
- 关 键 词:
- who 验证 指南