cgmp文件_工作对照品杂质对照品的接收处理保管标准程序sop

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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：Operating替代：Supersedes:ReviewDate:Procedure页码：第1页共5页PageNo.:1of5标题：工作对照品/对照品/杂质对照品的接收、处理和保管标准程序TITLE:RECEIPT,HANDLINGANDMAINTENANCEOFWORKING/REFERENCEANDIMPURITYSTANDARD1.0目的Purpose:描述工作

2、对照品/对照品/杂质对照品的接收、处理和保管的标准程序Tolaydownaprocedureforreceipt,handlingandmaintenanceofworkingstandard/referencestandardandimpurities.2.0范围Scope:本程序适用于工作对照品/对照品/杂质对照品的接收、处理和保管。这些对照品来自研发部门和外部原料药生产商。Thisprocedureisapplicableforreceipt,handlingandmaintenanceof

3、workingstandard/referencestandardandimpuritiesreceivedfromR&D&ExternalAPIvendor.3.0定义Definitions:无Nil4.0责任Responsibility:所有的QC人员有责任在他们的岗位上遵循此标准操作程序的操作。AllQCpersonalareresponsibleforfollowingthisSOPaspertheirrespectiveroles.5.0程序Procedure5.1接收Receipt:5

4、.1.1在接收的时候，检查是否有检验报告单（COA）和支持性数据。若没有，则向厂家索取。检查容器是否完好无损，对比COA和标签的内容。Atthetimeofreceipt,checktheavailabilityofCertificateofAnalysis(COA)andsupportingdata.Ifnot,thenaskthesourcetoprovidethem.ChecktheintactnessofcontainersandcomparethecontentsofCOAandlabe

5、l.5.1.2如果发现不符合之处，跟生产商联系来更正它。Ifanydiscrepancyisobserved,thencontactsuppliertocorrectthem.5.1.3按照附录-I的要求记录每个工作对照品/对照品/杂质对照品的接收细节。Recordthereceiptdetailsofeachworkingstandard/referencestandardandimpuritiesasperAnnexure-I.5.1.4接收的序号应被视为工作对照品/对照品/杂质对照品的内部编

6、码。制定人审核人批准人PreparedbyReviewedbyApprovedby签名/日期Sign/Date名字Name职务Designation文件编码Doc.No.:PageNo.:2of5标题：工作对照品/对照品/杂质对照品的接收、处理和保管标准程序TITLE:RECEIPT,HANDLINGANDMAINTENANCEOFWORKING/REFERENCEANDIMPURITYSTANDARDTheserialnumberofreceiptshouldbetreatedasIn-hous

7、eIDofworkingstandard/referencestandardandimpurities.5.1.5在COA上注明内部编码，把所有的COA按内部编码的顺序放在单独的文件夹里。MentionIn-houseIDontheCOAandkeepallCOAinaseparatefileasperIn-houseID.5.1.6关于原料药的工作对照品/对照品，检查一下COA和标签上是否折算过的含量。如果没有，用下面的公式，依据附录-II,计算折算后的含量。Forworking/referen

8、cestandardforAPI,checkifthepotencyon‘as-is-basis’isavailableonCOAandlabel.Ifnot,calculatethepotencyon‘as-is-basis’usingfollowingformulaasperAnnexure-II.5.2公式Formula:5.2.1如果含量是按无水物/干燥品计算Iftheassayisonanhydrous/driedbasis折算后的含量(%w/w)：Potencyof‘a