CLEANING-VALIDATION-PROTOCOL模板

CLEANINGVALIDATIONPROTOCOLFORSystemNameVersion:xxDateofVersion:DD-MMM-YYYYDocumentID:xxxxxx-xxx///THISPAGEMUSTBEDELETEDBEFOREPUBLICATIONThepurposeofthistemplateistoassistintheinterpretation,application,andpreparationoftheCleaningValidationProtocol.•ParagraphsinblueitalicsfontaremeanttoserveasinstructionstotheAuthorandshouldbedeletedinthefinaldocument.•Paragraphsinblackregularfontaresamplewordingthatmaybeusedasisormodifiedasneeded.Shouldaparagraphnotbeapplicable,deleteitfromthedocumentaltogether.•Redtextindicatesexampletext,whichmaybeusedifapplicable.Ifredtextdoesapplytoyoursystem/project,keepthetextandconvertthetextcolortoblack.Shouldtheredtextnotbeapplicable,deleteitfromthedocumentaltogether•Nosections,maybedeletedfromthedocument.Ifasectiondoesnotapply,thesectionheadingmustremainandastatementofnon-applicabilitymustbeaddedunderthatsection.•TextinBRACKETSshouldbereplacedwiththeappropriateinformationbytheAuthor.•Thedateofthedocumentversionneedstobeadded.ThedateistobeintheformatDD-MMM-YYYY.•ThedocumentIDisobtainedbyyourcompany’sSOP.•Itisstressedthatthisdocumentservesasaguidelineonly.Itwillrequiremodificationtoaccuratelyreflectthespecificprojectandcomputersystembeingimplementedorupgraded.DocumentPreparationSignaturesPreparedby:FirstNameLastName/PreparerDepartmentSignaturebytheXxxxxxxxxxxxxxxemployeeorconsultantresponsibleforpreparingthedocument.Date(DD-MMM-YYYY)Reviewedby:FirstNameLastName/ReviewerDepartmentSignaturebytheXxxxxxxxxxxxxxxemployeeorconsultantresponsibleforreviewingthedocument.Date(DD-MMM-YYYY)DocumentApprovalSignaturesBusinessOwner:FirstNameLastName/BusinessOwnerDepartmentSignaturebytheXxxxxxxxxxxxxxxemployeewhoisthebusinessownerofthesystem.Date(DD-MMM-YYYY)Development/TechnicalPersonnel:FirstNameLastName/Development/TechnicalDepartmentSignaturebytheXxxxxxxxxxxxxxxemployeeresponsibleforoverseeingthedevelopmentandtechnicalaspectsofthesystem.Date(DD-MMM-YYYY)ValidationUnit:FirstNameLastName/NewJerseySiteValidationSignaturebytheXxxxxxxxxxxxxxxemployeeresponsibleforthereviewandapprovalofthisdocumenttoensurecompliancewithXxxxxxxxxxxxxxxvalidationpractices.Date(DD-MMM-YYYY)QualityUnit:FirstNameLastName/QualityAssuranceDocumentationComplianceSignaturebytheXxxxxxxxxxxxxxxemployeeresponsibleforsystemqualitywhoperformsindependentreviewofcompletedand/orexecutedvalidationdocumentation.Date(DD-MMM-YYYY)VersionHistoryVersionDateofVersionRevisedByTitle/DepartmentDescriptionofChange1.0DD-MMM-YYYYFirstIssuance///EntertherelevantinformationintotheVersionHistorytablefortheDate(DD-MMM-YYYYformat),RevisedByandTitle/Departmentcolumns.Thefirstapprovedversionisalwaysversion1.0withadescriptionofchangebeing“FirstIssuance”.Subsequentversionsrequiredescriptionofchangedetailedbydocumentsection.///TABLEOFCONTENTS1INTRODUCTION............................................................................................................................71.1Purpose........................................................................................................................................................................71.2AcronymsandDefinitions.........................................................................................................................................71.3Schedule.......................................................................................................................................................................71.4References...................................................................................................................................................................71.5TeamsandResponsibilities........................................................................................................................................81.6Testinstrumentsandmaterials.................................................................................................................................82SAMPLINGPLAN........................................................................................................................103ACCEPTANCECRITERIA.........................................................................................................113.1Limitsoftheresidualactiveingredient..................................................................................................................113.2Limitsofthebioburden............................................................................................................................................133.3Appearanceinspectionacceptancecriteria............................................................................................................133.4Limitsoftheresidualdetergent..............................................................................................................................134TESTMETHODS..........................................................................................................................145REVALIDATIONREQUIREMENT