pic s 验证指南(vmp，dq,iq,oq,pq中英文)

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1、PIC/S验证指南第41页共41页PIC/S验证指南1.DocumentHistory2.INTRODUCTIONThebasicprinciplesandapplicationofqualificationandvalidationaredescribedinAnnex15tothePIC/SandEUGuidetoGMP.ThisdocumentcomprisesindividualRecommendationsonfourtopicsrelatingtoEquipmentQualificationan

2、dProcessValidationinpharmaceuticalmanufacture,asfollows:ØValidationMasterPlan.ØInstallationandOperationalQualification.ØNon-SterileProcessValidation.ØCleaningValidation.ThefourRecommendationscomprisingthisdocumentdefinegeneralprinciplespertainingtoeachofth

3、etopics.2.导言PIC/S和EUGMP指导原则的附录15中对确认(Qualification)和验证(Validation)的基本原则及应用进行了阐述。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：验证主计划安装和运行确认非无菌工艺验证清洗验证本文件中的建议确定了上述这四个方面的基本原则。2.1Purposeofthedocument2.1.1ThetopicsoftheseRecommendationdocumentsreflectsomeoftheareasinphar

4、maceuticalmanufactureidentifiedbybothInspectoratesandthePharmaceuticalIndustryasrequiringguidanceadditionaltothatgiveninthecurrentPIC/SGMPGuide.2.1.2ThepurposeofthisdocumentistoprovideguidanceforGMPinspectorsinreviewingtheissuescoveredtousefortrainingpurpo

5、sesandinpreparationforinspections.2.1本文件的目的2.1.1这些建议性文件的主题涉及的是那些审计人员和制药企业都认为需要对现行PIC/SGMP指导原则进行补充的领域。2.1.2本文件的目的在于给GMP审计人员提供一个指导文件，可用于培训和检查的准备工作。2.2Scopeofthedocument2.2.1ItisconsideredthattheprinciplesdefinedintheindividualRecommendationdocumentscanbeappl

6、iedequallyinthemanufactureofactivepharmaceuticalingredients(APIs)andfinishedpharmaceuticals.2.2.2Atthetimeofissue,thisdocumentreflectedthecurrentstateoftheart.Itisnotintendedtobeabarriertotechnicalinnovationorthepursuitofexcellence.2.2.3TheadviceintheseRec

7、ommendationsisnotmandatoryforindustry.However,PIC/S验证指南第41页共41页industryshouldconsidertheseRecommendationsasappropriate.2.2.4ItshouldbenotedthatadditionalrequirementsnotcontainedintheseRecommendationspertaintocomputersystemsimpactingGMP.2.2范围2.2.1每个建议文件中所确定

8、的原则既适用于原料药，也适用于制剂。2.2.2在公布时，本文件反映了当前的技术水平。但并不能因此而成为技术革新和追求卓越的一种障碍。2.2.3本文件中的建议并不强制制药企业执行。然而，制药企业应当要适当考虑这些建议。2.2.4需要注意的是本文件并未包括会影响GMP的计算机系统方面的附加要求。2.3AimsofQualificationandValidationThequalificationandvalidati