STANDARD OPERATING PROCEDURE OOS 调差 INVESTIGATION OF OUT-OF-SPECIFICATION RESULTS

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1、Page:SOP#:Eff.Date:Supersedes:17/173-0002.012016.7.202015.12.1STANDARDOPERATINGPROCEDURE题目：TitleOOS调查INVESTIGATIONOFOUT-OF-SPECIFICATIONRESULTS起草/修订人：Author日期：Date部门主管审查：Dept.HeadApproval日期：DateQA批准：ApprovedbyQA日期：Date分发：Distribution:QA,QC目的：所得的检验结果可以是与趋势不符（OOT）或不符合规定（OOS）。这些异常结果应进行确认，并且一旦被证实，应进行调

2、查，以找出根本原因。本规程提供了如何处理这种检验结果的详细的操作指导。PURPOSE:Analyticalresultsobtainedcouldbeatypical(outoftrend,OOT)orout-of-specification(OOS).Theseaberrantresultsrequireverificationand,ifverified,investigationintotheirrootcause.Thisprocedureprovidesdetailedinstructionsforconsistentandthoroughevaluationandinvesti

3、gationofsuchanalyticalresults.范围：本规程包含了数据的处理、最终结果的调查和记录；化验室负责与潜在的OOS或OOT结果有关的化验室所有调查的评价。SCOPE:Thisprocedurecovershandlingofdata,investigationanddocumentationoffinalresults.QClaboratoryhasresponsibilityfortheevaluationofallinvestigationsoflaboratorydataassociatedwithpotentialOOSorOOTresults.本规程适用于所

4、有按已批准的质量标准进行的检验。适用于，但不仅限于下述物料：Thisprocedureappliestoalltestingagainstapprovedspecification.Itapplies,butnotlimitedto,analyticalandphysicaltestingofthefollowingmaterials:—进厂物料。Incomingrawmaterials—中间体、中间控制样品及成品。Intermediates,In-processsamplesandfinalproducts—稳定性试验样品。Stabilitysamples—工艺验证和清洗验证的样品。Pr

5、ocessandcleaningvalidationsamples本规程不适用于：Thisproceduredoesnotapplyto:—在工艺研发（包括影响因素试验，或加速试验）过程中所产生的潜在的OOS/OOT，因为在工艺研发过程中，可能会出现预期的不符合规定限度的结果。PotentialOOS/OOTresultsobtainedduringprocessdevelopment(includesstressoracceleratedstudy),wheresomeresultsareexpectedtofalloutsideofestablishedlimits.—方法验证和方法确

6、认。Methodvalidationandverification—方法转移。Methodtransfer范围：（续）Page:SOP#:Eff.Date:Supersedes:17/173-0002.012016.7.202015.12.1STANDARDOPERATINGPROCEDURE题目：TitleOOS调查INVESTIGATIONOFOUT-OF-SPECIFICATIONRESULTSSCOPE:(Cont.)—新化验员培训过程中所产生的结果。Analystqualification—仪器确认/校正。Equipmentqualification/calibration参考文

7、件：REFERENCEANDATTACHMENT:SOP/题目SOP/TITLE记录/附件/题目FORMS/ATTACHMENTS/TITLE1-3002偏差调查附件1：化验室偏差调查流程图DeviationInvestigationAttachment1:LaboratoryInvestigationFlowChart附件2：化验室初步调查检查帮助清单Attachment2:AidtoAnalyst/Superviso