变更控制管理规程-中英文

控制文件ControlledDocument第1页共15Page1of15页文件名称FileName变更控制管理规程ChangeControlProcedure文件编号FileNo.SOP-Q00011.05起草人/日期PreparedBy/Date审核人/日期CheckedBy/Date批准人/日期ApprovedBy/Date执行日期EffectiveDate1目的建立正式的变更控制系统，以评估可能影响中间体或成品生产和控制的所有变更。PURPOSEToestablishanofficialchangecontrolsystemtoevaluateallchangesthatmayaffecttheproductionandcontroloftheintermediatesorfinalproduct.2范围本标准适用于公司生产品种变更的评价和变更过程的控制和管理。SCOPEItappliestoevaluatethechangesofproductsandtocontrolandmanagethechangeprocess.3责任RESPONSIBILITYQA部负责变更的管理和复审，QA部经理负责变更的批准；QADepartmentshouldmanageandreviewthechanges;QAManagerisresponsibleforapprovingthechanges.生产部门负责生产变更的申请及实施和管理；Productiondepartmentshouldapply,implementandmanagethechangesofproduction.QA负责质量标准变更的申请及实施和管理；QAshouldapply,implementandmanagethequalityspecificationschanges.QC负责分析方法变更的申请及实施和管理；QCshouldapply,implementandmanagethechangesforanalysismethods.设备部/工程部负责设备与设施的变更管理与申请；Equipment/Engineeringdepartmentshouldapplyandmanagethechangesforfacilities,supportsystemsandequipments.采购部负责物料变更管理与申请；Purchasedepartmentshouldapplyandmanagethechangesformaterials.质量管理部负责向国内药政机构如SFDA传递相关信息；QAdepartmentshouldreporttherelevantinformationtodomesticauthorities(suchasSFDA).外贸注册部负责向国外药政机构如FDA、EDQM及持有DMF资料的客户传递相关信息；RegulatoryAffairsDepartmentshouldreporttherelevantinformationtotheoverseaauthorities(suchasFDA、EDQM)andDMFrelatedcustomers.销售部门负责向其他客户提供变更的有关信息。SalesDepartmentshouldreporttherelevantinformationtoothercustomers.控制文件ControlledDocument第2页共15Page2of15页4定义DEFINITION变更是指药品生产质量系统各要素的改变。Changemeansanyalterationoccurredintheproductionandqualitysystem.5引用标准REFERENCEICHQ7a136适用范围PLICABLESCOPE6.1原料变更(包括供应变更)Changesofrawmaterials(includingthesupplierchanges);6.2质量规格变更Changesofspecifications6.3分析方法变更（包括检测条件，法定对照品批号的变更）Changesofanalysismethods;(includingthechangesofeithertestconditionsorbatchNo.ofprimaryreferencestandardsobtainedfromanofficiallyrecognizedsource)6.4设备与设施的变更Changesoffacilities,supportingsystemsandequipments;6.5工艺变更Changesofthemanufacturingprocesses;6.6包装材料与标签的变更Changesoflabelingandpackagingmaterials;6.7计算机软件的变更Changesofcomputersoftwares.6.8COS或其他证书持有人改变ChangesofholdersofCOSorothercertificates6.9生产场地的改变ManufacturingsiteChanges6.10产品批量增大与缩小Increasinganddecreasingforthebatchsize.控制文件ControlledDocument第3页共15Page3of15页6.11化学纯度和微生物质量证书的变更Changesofcertificatesforchemicalpurityandmicrobiologicalquality.6.12TSE证书的变更ChangesofTSEcertificates.7变更的类型CLASSESOFCHANGES根据变更的对生产工艺和产品质量(中间体)的影响程度，变更可分为关键、一般和微小变更三类。Accordingtotheinfluenceextenttothemanufacturingprocessandproduct(intermediate)quality,thechangesisclassifiedascriticalchange,majorchangeandminorchange.7.1关键变更：对中间体或成品质量有影响的变更，对质量影响分为降低，等同，提高。Criticalchanges:thechangeswhichwillimpacttheintermediatesorfinalproduct’squality.Theimpacttoqualitymaybeclassifiedtoreducing,equivalent,improving.7.1.1主要工艺路线及原料、辅料成份(处方)的改变。Changesofthemajorsynthesisprocessandingredientsofrawmaterialsandexcipients,suchasformula.7.1.2化学合成、精制所使用的起始物料和关键原料的改变。Changesofthestartingmaterialsandcriticalmaterialsusedforchemicalsynthesisandpurification。7.1.3厂房或生产地址的变更。Changesofbuildingsormanufacturingsites.7.1.4生产设施和设备的更新或扩容。Changingorextendingthecapacityofthemanufacturingfacilitiesandequipments.7.1.5产品内包材的变更。Changesofproduct’sprimarypackagingmaterials.7.1.6关键工艺条件和参数的改变，例如：消毒工艺、温度、压力、通气量、时间等。Changesofthecriticalprocessconditionsandparameters,suchas:disinfectivemethod,temperature,pressure,ventilationvolume,timeetc.7.1.7关键原材料、中间体、成品以及过程分析的分析方法的删除。控制文件ControlledDocument第4页共15Page4of15页Deletingtheanalysisprocedureforthecriticalrawmaterials,intermediates,andfinalproducts.7.1.8产品质量标准的变更(不包括限度标准的提高)。Changesoftheproduct’sspecifications.(excludedthetighteningoflimits)7.1.9精烘包工艺路线的变更。Changesofthepurification,dryingandpackagingprocess.7.1.10对药典已收载的分析方法的改变。Changesoftheanalyticalmethodswhichhasbeenadoptedinthepharmacopoeia.7.1.11对成品标签内容大幅度的改变。Greatlychangesofthelabelcontentforfinishedproducts.7.1.12非关键工艺条件和参数的变更，如合成、提取精制用原料、溶媒的调整以及加料顺序的改变等。Changesofnon-criticalprocessconditionsandparameters,suchas:theadjustmentofrawmaterialandsolventinthesynthesisandextraction,thechangesofmaterialloadingsequence.7.1.13在工艺规程范围内改变控制参数至更严格的范围或采用新的准确度更高的中间体检验方法。Changestostrictercontrolparametersbutstillwithintherangeofestablishedprocessprocedures,orchangesofadoptionnewandmoreaccuratetestingmethodforintermediates.7.1.14最终制造中使用的物质来源由植物或合成物变为TSE风险物质的变更。Changesofthesourcesofmaterialsusedinthefinalmanufacturingprocess,butturnfromplantsorcompoundssourcesintoTSErisksubstances7.1.15化学纯度和微生物质量风险提高原因对证书的变更。COSchangescausedbyrisingqualityriskofchemicalpurityormicrobiologicalquality.7.2一般变更：对中间体或成品质量没有影响的变更。Majorchanges:thechangeswhichwillnotimpacttheintermediateorAPI’squality.7.2.1原料药精烘包工序生产线使用同类型或相似的设备，或产品批量变更(数量级内)。Changesofproductbatchsize(withintheorderofmagnitude),orchangesthatusethesameorsimilarequipmentintheprocessofpurification,dryingandpackaging.控制文件ControlledDocument第5页共15Page5of15页7.2.2产品外包材的变更。Changesofthesecondarypackagingmaterials.7.2.3标签小幅度的变更。Smallchangesoflabels.7.2.4生产辅助设备（动力中心、计量器械）的变更。Changesofmanufacturingsupportsystems(powercenter,calibra