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1、--..--1.0PURPOSE:Toperformtheannualreviewofcomplaints,recalls,returnedorsalvageddrugproducts,notificationofrejectionforms,outofspecificationresultforms,criticalsystemchangecontrolforms,investigation/deviationreportforms,productspecifications,manufacturingandcontrolprocedures.2.0
2、SCOPE:2.1AllCustomercomplaints,recalls,returnedorsalvageddrugproducts,notificationofrejectionforms,outofspecificationresultforms,criticalsystemchangecontrolforms,investigation/deviationreportsthatoccurredthroughouttheyearwillbereviewedonanannualbasis.2.2Appliestoallproductsandth
3、edocumentspertainingtotheirmanufacture.3.0RESPONSIBILITY:3.1ItistheresponsibilityoftheQualityControl/StabilitySystemsTechniciantoprepareaseparateannualreportoneachproductthatismarketedbyCompany.3.2TheQualityAssuranceAssistantScientistand/ortheQAManagerisresponsibleforreviewingth
4、edocumentationfromselectedbatchesofeveryproduct.3.3TheQA/QCDirectorand/ortheQAManagerand/orQCManagerareresponsiblefor:3.3.1Reviewingeachproductsannualreport.word可编辑.--..--3.3.2Performreviewofrecalls,returnedorsalvageddrugproducts,notificationofrejectionforms,outofspecificationre
5、sultforms,criticalsystemchangecontrolforms,investigation/deviationreportforms.3.4TheRegulatoryAffairsParalegalisresponsibleforprovidingasummaryannualreviewreportofallcomplaintsbyproduct.3.5TheRegulatoryAffairsDirectorisresponsibleforreviewingthesummaryannualcomplaintreport.3.6Th
6、eQA/QCDirectorisresponsiblefornotifyingtheresponsibleofficialsofthecompanyinwritingifaninvestigationisperformedonReturnedDrugproductsoronDrugProductsthataresalvagedbecauseofimproperstorageconditions.4.0PROCEDURE:4.1Therecordsassociatedwithaselectedbatch/lotoffinishedproductforea
7、chbulkformula,includingallrawmaterialandpackagingmaterialrecordsthatareusedtomanufactureandpackagethebatch/lotofproductarereviewedforcontentandcompletenessannually.4.2Therecordsforcomplaints,recalls,returnedorsalvageddrugproducts,notificationofrejectionforms,outofspecificationre
8、sultforms,criticalsystemchangecontrolformsandin
