【精品】奥美拉唑钠工艺验证方案.doc

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1、SMPTechniquevalidationProtocolofOmeprazoleSodiumforInjectionPV-L-55FirstInjectionWorkshopIssuedbyZhejiangYaitaiPharmaceuticalCo.,ValidationProtocolTitleTechniqueValidationProtocolofOmeprazoleSodiumforinjectionIssueDepartmentProductionTechniqueDepartment10pagesNo.PV-L-55AvailabilityDateAugust1

2、5th,2008VerificationpropertyAlterationvalidationAgencyFirstInjectionworkshopMakerWangXingjiangEnactingDateAugust7lh,2008AuditorAuditingAugust10lApproverWangApprovalAugust14l2008Date2008LiyunDateCatalogI.Application2II.Responsibility2III.Overview2IV.ManufacturingTechniqueCompendiumofOmeprazo

3、leSodium(40mg)4V.ValidationItems5VI.ValidationSummary10TechniqueValidationProtocolofOmeprazoleSodiumforinjectionPV-L-55I.ApplicationThisprotocolisappliedtothealterationvalidation(productionfacilityalteration)ofOmeprazoleSodium(40mg).II.ResponsibilityPrincipalofworkshop:draftingandimplementing

4、ofvalidationprotocolandvalidationreport.ManagerofproductionTechniquedepartment:monitoringtheimplementingofvalidationprotocolManagerofQCdepartment:SamplingaccordingtotheSOPandsamplingprogramprescribedinthevalidationprotocol,andtimelypresentingtheresult.ManagerofQAdepartment:Overallcoordinating

5、validationtestsandauditingthevalidationprotocolandrelatedreports.DeputyGeneralManagerofqualitydepartment:approvingthevalidationprotocol.III.OverviewSinceomeprazolesodiumforinjection(40mg)isproducedinSecondinjectionworkshop,thequalityisbasicallystable.Toguaranteehighqualityofproduct,inthecondi

6、tionofmaintainingtherawmaterialmanufacturer,thefollowingfactorsarealteredandnecessarilytobevalidated.1.Tomeettherequirementofenlargemanufacturing,theworkshopofomeprazolesodiumistransferredfromfirstinjectiontosecondinjection,whereequipmentischanged.Detailsrefertomanufacturingtechniquesummaryan

7、dequipmentalterationchart.Thevolumeoffreezedryertransfersfrom20m2to10m2.Whereas,injectiontechniquedoesn'tchange.1.Themanufacturerofrawmaterialdoesn'tchange,andrawmaterialofomeprazolesodiumvalidatedisstillfromJinzhouJiutaiPharmaceuticalCo.,Ltd