瓶装线包装验证方案最终版

SHIJIAZHUANGYILINGPHARMACEUTICALCo.,LTD.石家庄以岭药业股份有限公司ProtocolNo.方案号:PKV-***PageNo.1of27BOTTLEPACKAGINGLINEVALIDATIONPROTOCOL瓶装线包装验证方案Itemcode产品代码:VersionNo.版本号:A00ProductName产品名称:CIPROFLOXACINTABLE250mgUSP环丙沙星片250mg瓶装线包装验证方案Effectivedate:生效日期：SupersedeNo.替代号:NAPreparedby起草人Reviewedby审核人Approvedby批准人IssuedBy:(QA):_____________(Sign&Date)Designation职务Certificationstaff验证人员EquipmentManager设备部经理ProductionManager生产部经理QAManagerQA经理QP-CRESCENTPHARMALIMITEDSignature签名Date日期BOTTLEPACKAGINGLINEVALIDATIONPROTOCOLOFCIPROFLOXACINTABLES250mgUSP环丙沙星片250mg瓶装线包装验证方案SHIJIAZHUANGYILINGPHARMACEUTICALCo.,LTD.石家庄以岭药业股份有限公司ProtocolNo.方案号:PKV-***PageNo.2of27BOTTLEPACKAGINGLINEVALIDATIONPROTOCOL瓶装线包装验证方案Itemcode产品代码:VersionNo.版本号:A00ProductName产品名称:CIPROFLOXACINTABLE250mgUSP环丙沙星片250mg瓶装线包装验证方案Effectivedate:生效日期：SupersedeNo.替代号:NA1.0PURPOSE:目的ToestablishthatthepackagingprocessforCiprofloxacinTablets250mgwillmeetthepredeterminedspecificationsandqualityattributesconsistently.保证异烟肼片100mg瓶装线的包装过程能够符合预定规范和质量品质。2.0SCOPE:范围ThisprotocolisapplicableforPackagingvalidationofCiprofloxacinTablets250mgatSHIJIAZHUANGYILINGPHARMACEUTICALCo.,LTD.本方案适用于石家庄以岭药业有限公司环丙沙星片250mg瓶装线的包装验证。3.0RESPONSIBILITIESOFVALIDATIONTEAM:验证小组职责CertificationStaff验证人员Responsibleforpreparation,issueofpackagingvalidationprotocolandexecutionofpackagingvalidation.负责准备工作，编写与执行包装验证方案EquipmentManager设备部经理Responsibleforcheck,check(review),approvepackagingvalidationprogramandensureverificationschemecanachieveverifycompliancewithregulationsstandard负责核实、复核、批准包装验证方案，确保验证方案可以达到验证标准符合规定Head-ProductionDept.生产部经理Responsibleforverificationofpackagingvalidationprotocolandtoensureoperationofthepackagingequipment&supportsystemsinordertopacktheproductwithinitsdesignlimits/specifications/requirement.负责核实包装验证方案，确保生产设备及维护系统运行生产的产品符合设计规格Head-QualityControl:QC经理Responsibleforverificationofpackagingvalidationprotocolandtoensureoperationoflabactivitiestoachieveoptimumcriticalparameters负责核实包装验证方案，确保化验室的检验活动符合要求，以确定和实现最佳关键参数Head-QualityAssurance:QA经理Reviewandapprovalplan,reviewthespecificproductionprocessescomplywithGMPregulations.Alsoresponsibleforresultassessment,packingandpackagingrecordsofvalidationconclusionsrelatedtorevise.复核与批准方案，审核具体生产流程符合GMP相关规定。同时负责结果评估，包装验证结论还有批包装记录相关修订。SHIJIAZHUANGYILINGPHARMACEUTICALCo.,LTD.石家庄以岭药业股份有限公司ProtocolNo.方案号:PKV-***PageNo.3of27BOTTLEPACKAGINGLINEVALIDATIONPROTOCOL瓶装线包装验证方案Itemcode产品代码:VersionNo.版本号:A00ProductName产品名称:CIPROFLOXACINTABLE250mgUSP环丙沙星片250mg瓶装线包装验证方案Effectivedate:生效日期：SupersedeNo.替代号:NA4.0ACCEPTANCECRITERIA:可接受标准Alltheproductqualityparametersmustcomplywiththeacceptancecriteriaasspecifiedinthisprotocolconsistentlyforthreeconsecutivebatchesbyoptimizingthecriticalpackagingparametersduringthefirstbatch.通过第一个批次确定关键包装参数及其范围，共进行三个连续批次，所有产品质量必须满足本方案确定的接受标准，通过第一个批次确定的合格的关键包装参数，共进行三个连续批次，所有产品质量必须满足本方案确定的标准5.0PROCEDURE:规程ExecutethreeconsecutivebatchesasperBatchPackagingRecord.Recordthecriticalparametersofthepackagingunitoperationsasdescribedinthisprotocolandcompilesubsequenttestreport.Optimizethecriticalparametersduringvalidationoffirstbatchandtheoptimizedparameterstobeverifiedinnexttwoconsecutivebatches.Raise(Submit)DeviationReportasperYLS-SOP-QA002,ifanyabnormalitiesfoundduringtheentirepackagingvalidation.Ifrequired(Ifnecessary),CorrectiveactionsandpreventiveactionstobetakenasperSOPNo.:YLS-SOP-QA033beforeproceedingtonextbatch.根据批包装记录进行三个连续批次。记录本方案所描述的包装机的关键运行参数。在第一批次验证时找到最佳关键参数，应用在最后的两个连续批次当中。如在整个包装验证过程中出现任何异常，根据YLS-SOP-QA002提交偏差报告。如果必要，在下一批次进行前根据操作规程YLS-SOP-QA033进行纠正及相关预防措施。6.0产品详细BrandName:产品名称：CiproflxacinTablets250mg环丙沙星片250mgB.Size:批量：150万片ShelfLife:有效期：DosageForms:剂型：片剂GenericName仿制药名称：CiproflxacinTablets250mg环丙沙星片250mgContractGiver：合同方：AscendLaboratoriesLLC阿森达ProductCode:产品代码：FP00003PackSize包装规格：30片/瓶LabelClaim:标签声明：Averageweight:平均片重：185.0-215.0mgSHIJIAZHUANGYILINGPHARMACEUTICALCo.,LTD.石家庄以岭药业股份有限公司ProtocolNo.方案号:PKV-***PageNo.4of27BOTTLEPACKAGINGLINEVALIDATIONPROTOCOL瓶装线包装验证方案Itemcode产品代码:VersionNo.版本号:A00ProductName产品名称:CIPROFLOXACINTABLE250mgUSP环丙沙星片250mg瓶装线包装验证方案Effectivedate:生效日期：SupersedeNo.替代号:NA7.0REFERENCEDOCUMENTSFORMETHODOFPACKAGINGANDTESTING:包裝与测试方法参考文件S/No序号NAMEOFTHEDOCUMENT文件名称DocumentNumber文件编号1Picklist包装指令PP*****2BatchPackagingRecord批包装记录BPR-0153ProductspecificationsandTestProcedure产品标准和检验方法YLS-QS-FP003；YLS-QTM-FP0014Testmethodofleakagetest密封试验测试方法YLS-QTM-GR095Note:AllapprovedcurrentversionofrelevantSOPsanddocumentsmustbereferred.注:必须列出所有涉及到的现行SOP和文件8.0REASONFORVALIDATION:验证原因Reasons原因Tickintheappropriaterow在相应项目上划√CommercialManufacturingofpre-approvedproduct注册批准产品商业生产√SHIJIAZHUANGYILINGPHARMACEUTICALCo.,LTD.石家庄以岭药业股份有限公司ProtocolNo.方案号:PKV-***PageNo.5of27BOTTLEPACKAGINGLINEVALIDATIONPROTOCOL瓶装线包装验证方案Itemcode产品代码:VersionNo.版本号:A00ProductName产品名称:CIPROFLOXACINTABLE250mgUSP环丙沙星片250mg瓶装线包装验证方案Effectivedate:生效日期：SupersedeNo.替代号:NA9.0包装材料列表S.No.序号ItemCode物料代码NameofthePackingMaterial包材名称Description描述Quantity数量Units单位1P00013120mlHDPEBottle120mlHDPE瓶120ml2P00114120mlHDPEBottleCap120mlHDPE瓶盖17.15mm*43.80mm3P00041Shrinkfilm热收缩膜245mm×18μm4P00272Shi