pic s vmp 验证主计划（中英文对照）

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1、RECOMMENDATIONSONVALIDATIONMASTERPLANINSTALLATIONANDOPERATIONALQUALIFICATIONSTERILEPROCESSVALIDATIONCLEANINGVALIDATION(1/25)1.DOCUMENTHISTORYAdoptionbyPIC/SCommittee10-11December1998EntryintoforceofversionPR1/99-101March1999EntryintoforceofversionPI006-101September20012.INTRODUCTION2.1.

2、2本文件的目的在于给GMP审计人员提供一个指导Thebasicprinciplesandapplicationof文件，可用于培训和审计的准备工作。qualificationandvalidationaredescribed2.2ScopeofthedocumentinAnnex15tothePIC/SandEUGuidetoGMP.2.2.1ItisconsideredthattheprinciplesdefinedThisdocumentcomprisesindividualRecommendationsintheindividualRecommendationd

3、ocumentscanbeonfourtopicsrelatingtoEquipmentQualificationappliedequallyinthemanufactureofactiveandProcessValidationinpharmaceuticalpharmaceuticalingredients(APIs)andfinishedmanufacture,asfollows:pharmaceuticals.ØValidationMasterPlan2.2.2Atthetimeofissue,thisdocumentreflectedØInstallatio

4、nandOperationalQualificationthecurrentstateoftheart.ItisnotintendedtoØNon-SterileProcessValidationbeabarriertotechnicalinnovationorthepursuitØCleaningValidationofexcellence.ThefourRecommendationscomprisingthisdocument2.2.3TheadviceintheseRecommendationsisnotdefinegeneralprinciplespertai

5、ningtoeachofthemandatoryforindustry.However,industryshouldtopics.considertheseRecommendationsasappropriate.2.导言2.2.4ItshouldbenotedthatadditionalrequirementsnotcontainedinthesePIC/S和EUGMP指导原则的附录15中对确认Recommendationspertaintocomputersystems(Qualification)和验证(Validation)的基本原则及应impactingGM

6、P.用进行了阐述。2.2范围本文件包含了药物生产过中与设备确认和工艺验证相关的如下这四个方面的建议：2.2.1每个建议文件中所确定的原则既适用于原料药，也适用于制剂。验证方案安装和运行确认2.2.2在公布时，本文件反映了当前的技术水平。但并非无菌工艺验证不能因此而成为技术革新和追求卓越的一种障碍。清洗验证2.2.3本文件中的建议并不强制制药企业执行。然而，本文件中的建议确定了上述这四个方面的基本原则。制药企业应当要适当考虑这些建议。2.1Purposeofthedocument2.2.4需要注意的是本文件并未包括会影响GMP的计算2.1.1Thetopicsofthe

7、seRecommendationdocuments机系统方面的补充要求。reflectsomeoftheareasinpharmaceutical2.3AimsofQualificationandValidationmanufactureidentifiedbybothInspectoratesandThequalificationandvalidationprocessshouldthePharmaceuticalIndustryasrequiringguidanceestablishandprovidedocumentaryevidencetha