DocumentControls(cGMP培训系列3)

RecordsandReportsGMPTrainingModule3GeneralRequirements•Whatarethegeneralrequirementsfordocumentcontrol?•Howlongdoyoukeeprecordsandreportsrelatedtoproduction,controlanddistribution?GeneralRequirementsa)Anyproduction,control,ordistributionrecordthatisrequiredtobemaintainedincompliancewiththispartandisspecificallyassociatedwithabatchofadrugproductshallberetainedforatleast1yearaftertheexpirationdateofthebatchor,inthecaseofcertainOTCdrugproductslackingexpirationdatingbecausetheymeetthecriteriaforexemptionunder211.137,3yearsafterdistributionofthebatch.a)任何生产、控制或销售记录，须依照本部分要求特别是与一批药品有关的上述记录，在该批药品有效期满后，保留一年以上。一些无有效期的非处方药品，由于它们符合211∙137的标准，在该批药品销售后，保留三年。Doyoualsokeeprecordsforallcomponents,drugproductcontainers,closures,andlabeling?Forhowlong?Wheredoyoukeepalltheserecords?Aretheyreadilyavailable?Showmeallrelatedrecordsofabatchmadeon10/10/2009(oneyearago).(b)Recordsshallbemaintainedforallcomponents,drugproductcontainers,closures,andlabelingforatleast1yearaftertheexpirationdateor,inthecaseofcertainOTCdrugproductslackingexpirationdatingbecausetheymeetthecriteriaforexemptionunder211.137,3yearsafterdistributionofthelastlotofdrugproductincorporatingthecomponentorusingthecontainer,closure,orlabeling.(b)全部成份，药品容器、密封件及标签的记录，在有效期满后，保留一年以上。一些无有效期的非处方药品，由于它们符合211∙137规定的免除的标准，故从销售最后一批药品计，上述记录保留三年。(c)Allrecordsrequiredunderthispart,orcopiesofsuchrecords,shallbereadilyavailableforauthorizedinspectionduringtheretentionperiodattheestablishmentwheretheactivitiesdescribedinsuchrecordsoccurred.Theserecordsorcopiesthereofshallbesubjecttophotocopyingorothermeansofreproductionaspartofsuchinspection.Recordsthatcanbeimmediatelyretrievedfromanotherlocationbycomputerorotherelectronicmeansshallbeconsideredasmeetingtherequirementsofthisparagraph.(c)本部分要求的全部记录或它们的拷贝，应能随时调出以便授权检查人员复核。这些记录应可以复印或其他方法复制。直接从电子计算机或其它设备中提出的记录，符合本段的要求。(d)Recordsrequiredunderthispartmayberetainedeitherasoriginalrecordsorastruecopiessuchasphotocopies,microfilm,microfiche,orotheraccuratereproductionsoftheoriginalrecords.Wherereductiontechniques,suchasmicrofilming,areused,suitablereaderandphotocopyingequipmentshallbereadilyavailable.(d)本部分要求的记录，可用原始记录或复印件，如光电复印、缩微胶卷和其他可以对文件精确复制的方式。如是缩微方式，应配备适合阅读和复印设备。Doyouhaveanannualreviewtoevaluatequalitystandardsforeachdrugproduction?Ifso,howmanybatchesdoyoureview?Howmanybatchesdidyoureviewlastyear?ShowmetheannualreviewreportonBZKwipeproductlastyear.Doyoureviewcomplaints,recalls,returnedorsalvageddrugproducts,andinvestigationsconductedunder211.192foreachdrugproduct?Pleaseshowmeanexampleofsuchinvestigation.(e)Writtenrecordsrequiredbythispartshallbemaintainedsothatdatathereincanbeusedforevaluating,atleastannually,thequalitystandardsofeachdrugproducttodeterminetheneedforchangesindrugproductspecificationsormanufacturingorcontrolprocedures.Writtenproceduresshallbeestablishedandfollowedforsuchevaluationsandshallincludeprovisionsfor:(1)Areviewofarepresentativenumberofbatches,whetherapprovedorrejected,and,whereapplicable,recordsassociatedwiththebatch.(2)Areviewofcomplaints,recalls,returnedorsalvageddrugproducts,andinvestigationsconductedunder211.192foreachdrugproduct.(e)保留本部分所要求的文字记录，其中的资料可用作评价至少一个年度每个药品的质量标准，决定药品的规格、生产或控制程序中需要更改的地方。根据这些评估制订文字程序，并包括下列条款：1)评估一定数量生产批次所有相关记录，无论这些批次是批准/拒收。2)投诉、撤销、退回或报废药品的复查，按211∙192对每个药品进行调查。•Areresponsibleofficialsofyourcompanynotifiedinwritingofanyinvestigationsconductedunder211.198(complaint),211.204(return),or211.208(salvage)oftheseregulations,anyrecalls,reportsofinspectionalobservationsissuedbyFDA,oranyregulatoryactionsrelatingtoGMPbroughtbyFDA?(f)Proceduresshallbeestablishedtoassurethattheresponsibleofficialsofthefirm,iftheyarenotpersonallyinvolvedinorimmediatelyawareofsuchactions,arenotifiedinwritingofanyinvestigationsconductedunder211.198,211.204,or211.208oftheseregulations,anyrecalls,reportsofinspectionalobservationsissuedbytheFoodandDrugAdministration,oranyregulatoryactionsrelatingtogoodmanufacturingpracticesbroughtbytheFoodandDrugAdministration.(f)应建立程序以确保以书面形式通知企业负责人关于211∙198（投诉）、211∙204（退货）或211∙208（报废）等条款的任何调查结果、以及任何产品召回、FDA发出的稽查报告或FDA发出的关于GMP生产相关的法规和措施。企业负责人如直接参与此类活动或立即知悉相关信息则不需要书面通报。EquipmentcleaninganduselogDoyouhaveindividualequipmentlog?Ifnot,couldyouexplainwhy?Canyoushowmeabatchrecordthathastheinformationofcleaning,maintenanceanduse?Doyouhavetwopersons,oneperformsthecleaning/maintenanceandtheotheronedoublecheck?Showmeacleaning/machinemaintenancerecordon10/6/2010.EquipmentcleaninganduselogAwrittenrecordofmajorequipmentcleaning,maintenance(exceptroutinemaintenancesuchaslubricationandadjustments),anduseshallbeincludedinindividualequipmentlogsthatshowthedate,time,product,andlotnumberofeachbatchprocessed.Ifequipmentisdedicatedtomanufactureofoneproduct,thenindividualequipmentlogsarenotrequired,providedthatlotsorbatchesofsuchproductfollowinnumericalorderandaremanufacturedinnumericalsequence.Incaseswherededicatedequipmentisemployed,therecordsofcleaning,maintenance,anduseshallbepartofthebatchrecord.Thepersonsperforminganddouble-checkingthecleaningandmaintenance(or,ifthecleaningandmaintenanceisperformedusin