瓶装线包装验证方案最终版.docx

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1、BOTTLEPACKAGINGLINEVALIDATIONPROTOCOLOFCIPROFLOXACINTABLES250mgUSP环丙沙星片250mg瓶装线包装验证方案1.0PURPOSE: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Thisprotocol

2、isapplicableforPackagingvalidationofCiprofloxacinTablets250mgatSHIJIAZHUANGYILINGPHARMACEUTICALCo.,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,issueofpackagingvalidationprotocolandexecutionofpackagingv

3、alidation.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Responsibleforverificationofpackagi

4、ngvalidationprotocolandtoensureoperationofthepackagingequipment&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Responsibleforverificationofpackagingvalidationprotocolandtoensureoperationofl

5、abactivitiestoachieveoptimumcriticalparameters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,packingandpackagingrecordsofvalidationconclusionsrelatedtor

6、evise.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。3.0ACCEPTANCECRITERIA:可接受标准Alltheproductqualityparametersmustcomplywiththeacceptancecriteriaasspecifiedinthisprotocolconsistentlyforthreeconsecutivebatchesbyoptimizingthecriticalpackagingparametersduringthefirstbatch.通过第一个批次确定关键

7、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.Optimize