gbc-007 process validation

精品资料网（）25万份精华管理资料，2万多集管理视频讲座精品资料网（）专业提供企管培训资料PROCTER&GAMBLEGLOBALBEAUTYSTANDARDOPERATINGPROCEDURE_______________________________________________________________________Title:ProcessValidationSOPNo:GBC-007Revision:3IssueDate:08/DEC/2006EffectiveDate:15/JAN/2007ApprovalSignatures:Originator:SOFPerExceptionGBU-1-2006Date:M.NairBeautyQADirectorSPRiedellDate:01/DEC/2007M.PolitisPURPOSEThisSOPprovidesaprocedureforqualificationandvalidationofproductionprocesses,equipments,utilitysystems,facilitiesandlaboratoryequipment.SCOPECleaning&SanitizationValidation,TestMethodValidation,ComputerSystemValidationandWaterTreatmentSystemValidationarecriticalsystemstobevalidatedatallsites.SpecificvalidationrequirementsforthesesystemsaredescribedintherelevantSOPsandCorporateQualityGuidancedocumentslistedunderthereferencesectionofthisSOP.ThisSOPappliestoalldrug,cosmetic,anddeviceproductsandprocessesmanufacturedinBeautyCareProductSupply(PS)facilitiesincludingJointVentures/Licensees.ThisSOPmayalsobeusedatcontractmanufacturingoperations.AnydeviationfromthisSOPrequiressoundtechnicaljustificationandmustbeapprovedbythesiteQAmanager.RESPONSIBILITIESFornewproducts,lineextensions,andformulationchanges,ProductDevelopment(PD)orTechnicalServices(TS)hasleadresponsibilitytoassureprocessvalidationisconductedandcompleted.Thisincludesensuringthatcriticalprocessingparametersandacceptablerangesareidentified,andrequireddocumentsarewritten,includingthePerformanceQualification(PQ)ProtocolandthePQReport.ProductSupply(PS)hasresponsibilitytowriteandexecutetheInstallationQualification(IQ)andOperationQualification(OQ)protocol.ThisincludesresponsibilitytopreparetheIQ/OQReport.Forexistingpackingprocesses,makingprocesses,utilities,facilities,andlaboratoryequipmentusedinthemanufactureofexistingproductsandchangestothesesystems,thesiteshaveleadresponsibilitytoassureprocessvalidationisconductedandcompleted.Thisincludesleadresponsibilitytowritetherequireddocuments.ThesiteQAManagerwillassurevalidationfilesexistandarekeptcurrent.TheSiteQAMangerwillensurethataValidationMasterplanisavailableatsite.TheSiteQAManager,andOperationsManagerortheirdesigneewillreviewandapproveallIQ/OQandPQprotocolsandreports.ThePDorTSSectionHeadordesigneewillreviewandapproveallPQprotocolsandreportsfornewinitiatives.PROCEDURESOPNo:GBC-007Revision:3Page2of31IfPrinted,thisDocumentExpires24hourspast9/21/201910:33PMPriortoanyvalidationworkalltheprotocolsmustbeapproved.Allvalidationdatamustbereferencedorattachedwiththefinalvalidationreport.AllValidationprotocolswillneedtobereferencedwithaprotocolnumberidentifyingthespecificvalidation,preferredoptionswouldbetoabbreviatetheplantnameorincludethesitecodee.g.C&SvalidationscanbereferencedasCS0491xxxxoramakingequipmentvalidationasMKG0491XXXXwhere0491isthesiteID.AllcompletedValidationdocumentsmustbeappropriatelyfiledforfuturereference.BelowformatandsectionsdescribethedetailedrequirementsforconductingInstallationQualification,OperationalQualificationandPerformanceQualificationInstallationQualification/OperationalQualificationProtocolThefollowingformatandsectionsaretobeaddressedinthedevelopmentofanIQ/OQprotocol.INSTALLATIONQUALIFICATION/OPERATIONALQUALIFICATIONPROTOCOLProjectorEquipmentNameValidationprotocolNumber:XXXXDateA.OBJECTIVEStatetheobjective(s)oftheequipmentqualification.B.SYSTEMDESCRIPTIONProvideadescriptionofthepurposeandmethodofoperationforthesystembeingqualified.C.TESTASSUMPTIONS/BOUNDARIESProvideabriefnarrativetodescribebaseassumptionsassociatedwiththequalification.Clearlystatetheboundariesofthesystemandtheoperatingconditions,whichthequalificationwillevaluate.D.RESPONSIBILITIESInthissection,listtheindividualsbynameswhoareresponsibleforconductingeachelementoftheEquipmentQualification.INSTALLATIONQUALIFICATION(IQ)InstallationQualificationinvolvesestablishingdocumentedevidencethatprocessequipmentandancillarysystemsequipmentareconstructedandinstalledtomeetdesignintent.IQdoesnottypicallyincludeoperationoftheequipment.IQmayonlyneedtobeperformedonceafterinitialinstallation.Thereafter,IQmaynotberequiredforeachdifferentprocessvalidation.AllorpartsofIQmayneedtoberepeatedfollowingrelocationofequipmentormajorrepairs,renovationsormodificationstotheequipment.E.EQUIPMENTLIST&DESCRIPTIONListallmajorequipmentandprovideabriefdescriptionofthefunction/constructionofeach.F.ENGINEERINGSPECIFICATIONS1.DrawingList-Providealistoftheapproveddrawingswhicharepertinenttothesystemincludingflowdiagrams,equipmentlayout,P&ID's,etc.2.InstrumentList-Listallkeyinstrumentsthatareassociatedwiththesystem,usingmanufacturer'snameanddescription.Includingequipmentnumbersfromthedrawingswillbehelpful.Instrumentscanbebrokenintotwocategories-critical,andnon-critical.Ifcriticalinstruments(i.e.,instrumentsrequiringcalibration)arelistedintheCalibrationsection,theyneednotbelistedinthissection.3.UtilityRequirements-Discusshereutilityrequirementsincludingcompressedair,treatedwater,potablewater,steam,etc.Hookupstothesesystemsshouldbeverifie