CGMP文件 回收溶媒的取样及批准程序SOP.pdf

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1、文件编码Doc.No.:标准操作程颁发日期：生效日期：序IssueDate:EffectiveDate:Standard复审日期：OperatingReviewDate:替代：Supersedes:Procedure页码：第1页共4页PageNo.:1of4标题：回收溶媒取样及放行程序TITLE:PROCEDUREFORSAMPLINGANDAPPROVALOFRECOVEREDSOLVENTS1.0目的Purpose:描述回收溶媒的取样及放行的程序。Describetheproceduretobefollowedforthesa

2、mplingandapprovalofrecoveredsolvents.2.0范围Scope:本程序适用于不同产品生产过程中各个阶段所得到的回收溶媒。Thisprocedureappliestosolventsrecoveredfromallstagesofdifferentproductsduringtheirmanufacturingprocess.3.0定义Definitions:无Nil4.0职责Responsibility:QC检验员以上职位的人员负责回收溶媒的取样及分析。Theresponsibilityofsamp

3、lingandanalysisoftherecoveredsolventslieswiththestaffofcadrenotlowerthanQCanalyst.5.0程序Procedure:.1回收溶媒取样的程序ProcedureforSamplingRecoveredSolvents:5.1.1当收到生产部门回收溶媒全检的“请验单”后，QC检验员应在各自的QC来样登记本中登记并编制检验报告单号。Afterreceivingthe‘RequestforSamplingandAnalysisSlip’fromproduction

4、forcompleteanalysisofrecoveredsolvent,QCanalystshouldmakeanentryintherespectiveRecoveredSolventInwardRegisterandassignanA.RNo...2QC检验员带上取样工具到回收溶媒存放地点进行取样，取样证需贴在桶上，同时在样品瓶上贴上识别标签。QCanalystshouldproceedtoconcernedareawheretherecoveredsolventstoredwithsamplingdevices,atta

5、chthe‘Sampled’labelstodrumsandattachsampleidentificationlabelstothesamplebottle...3检验员要穿戴必需的防护服。Theanalystshouldwearnecessarypersonnelprotectiveequipment...4核对回收溶媒桶上标签的名称与批号，应与“请验单”上的相一致。CheckthelabelontherecoveredsolventdrumforthenameoftherecoverysolventandbatchNo.as

6、per‘RequestforSamplingandAnalysisSlip’.5.1.5假如回收溶媒装有多桶的话，需用洁净且干燥的液体取样器分别从各桶取样。如发现外观异常，应单独取样。Collectsamplefromalldrumsifrecoveredsolventstoredindrumswithacleanedanddriedliquidsamplingdevices.Ifappearancefoundabnormal,theindividualsamplesshouldbecollected.5.1.6取样后，QC检验员

7、需在所有被取样的桶上贴上取样证，并在取样证上注明该溶媒的相关的信息。Aftercollectingsample,QCanalystshouldpaste‘Sampled’labelindicatingtherelevantdetailsofthesolventonalldrumsfromwhichsamplesaretaken.5.1.7在一个1L的样品瓶中将样品充分混合以得到一个混合样，在瓶上贴上标签注明样品信息。从中倒出250ml以供分析检验。Mixthecollectedsamplesthoroughlyina1-liter

8、samplebottletomakeacompositesampleandfixlabelonsamplebottleindicatingthesampledetails.Take250mlofthemixedsamplefortheanalysi