欧盟gmp指南中英文 (中英文)附录2 WHO药品GMP指南.doc

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1、欧盟gmp指南中英文(中英文)附录2WHO药品GMP指南导读：就爱阅读网友为您分享以下“(中英文)附录2WHO药品GMP指南”的资讯，希望对您有所帮助，感谢您对92to的支持!6.6Thedistributionrecordsshouldbereadilyavailabletotheauthorizedperson,andtheyshouldcontainsufficientinformationonwholesalersanddirectlysuppliedcustomers(including,forexportedproduct

2、s,thosewhohavereceivedsamplesforclinicaltestsandmedicalsamples)topermitaneffectiverecall.6.6受权人应当容易查询销售记录，记录中应包含批发商和直接供应客户的详细信息（对于出口产品，销售记录还应包含作为临床试验样品和医用样品的客户），使得该产品能够有效召回。6.7Theprogressoftherecallprocessshouldbemonitoredandrecorded.Recordsshouldincludethedispositionof

3、theproduct.Afinalreportshouldbeissued,includingareconciliationbetweenthedeliveredandrecoveredquantitiesoftheproducts.6.7产品的召回情况应当监控并记录。记录应包含对召回产品的处理。应签发最终的处理报告，其中包括产品的发放量和收回量之间的平衡。6.8Theeffectivenessofthearrangementsforrecallsshouldbetestedandevaluatedfromtimetotime.6.8

4、应当随时检测和评估产品召回处理的有效性。7.Contractproduction,analysisandotheractivities7委托生产、检验和其他活动7.1Principle.Contractproduction,analysisandotheractivitycoveredbyGMPmustbecorrectlydefined,agreedandcontrolledinordertoavoidmisunderstandingsthatcouldresultinaproductorworkoranalysisofunsati

5、sfactoryquality.7.1原则.为避免可能造成的产品、工作或检验问题的误解，GMP所涵盖的委托生产、分析和其他活动必须准确的定义，并经双方同意和共同监控。General概述7.2Allarrangementsforcontractproductionandanalysis,includingtechnologytransferandanyproposedchangesintechnicalorotherarrangements,shouldbeinaccordancewiththemarketingauthorizatio

6、nfortheproductconcerned.7.2委托生产和检验的所有协议，包括技术转移和技术或其他方面所做的变更，均应符合有关产品销售许可的要求。7.3Thecontractshouldpermitthecontractgivertoauditthefacilitiesandactivitiesofthecontractacceptorormutuallyagreedsubcontractors.7.3合同应准许委托方审计被委托方或双方同意的分包商的生产设施和活动。7.4Inthecaseofcontractanalysis,t

7、hefinalapprovalforreleasemustbegivenbytheauthorizedpersoninaccordancewithGMPandthemarketingauthorizationasspecifiedinthecontract.7.4委托检验时，应由受权人根据合同中规定的GMP和上市许可决定产品的最终放行。Thecontractgiver委托方7.5ThePQSofthecontractgivershouldincludethecontrolandreviewofanyoutsourcedactiviti

8、es.Thecontractgiverisresponsibleforassessingthelegality,suitabilityandcompetenceofthecontractacceptorinsuccess