CGMP文件藥典對照品的接收儲存使用和保管程序SOP

1、標準操作程序StandardOperatingProcedure文件編碼Doc.No.:頒發(fā)日期：IssueDate:生效日期：EffectiveDate:替代：Supersedes:復(fù)審日期ReviewDate:貝碼：第1頁共4頁PageNo.:1of4標題：藥典對照品的接收、儲存、使用和保管程序TITLE:PROCEDUREFORRECEIPT,STORAGE,USEANDMAINTENANCEOFPHARMACOPOIEALREFERENCESTANDARD1.0目白Purpose:規(guī)定藥典對照品的接收、儲存、使用和保管程序。Tolaydownaprocedureforreceipt,s

2、torage,useandmaintenanceofpharmacopoiealreferencestandard.2.0范圍Scope:本SOP適用于QC實驗室從藥典部門(USP/BP/EDQM/NICPBP)接收的所有對照品。ThisSOPappliestoallreferencestandardsusedintheQClaboratory,whicharereceivedfrompharmacopoiealagencies(USP/BP/EDQM/NICPBP).3.0定義Definitions:USP：美國藥典UnitedStatesPharmacopoeiaBP:英國藥典Britis

3、hPharmacopoeiaEDQM:歐洲藥品質(zhì)量理事會EuropeanDirectoratefortheQualityofMedicinesNICPBP:中國藥品生物制品檢定所NationalInstitutefortheControlofPharmaceuticalandBiologicalProducts4.0責任Responsibility:QC檢驗員/組長/經(jīng)理助理/經(jīng)理QCanalysts/GroupLeader/AssistantManager/Manager5.0程序Procedure:5.1 接收和儲存Receiptandstorage5.1.1 對照品應(yīng)從藥典部門或其授權(quán)代

4、理機構(gòu)購買。Referencestandardsshouldbeprocuredfrompharmacopoiealagencyorbytheirauthorizedagent.制定人Preparedby審核人Reviewedby批準人Approvedby簽名/日期Sign/Date名字Name職務(wù)Designation標題：藥典對照品的接收、儲存、使用和保管程序TITLE:PROCEDUREFORRECEIPT,STORAGE,USEANDMAINTENANCEOFPHARMACOPOIEALREFERENCESTANDARD5.1.2 接收對照品時應(yīng)從下列網(wǎng)站下載最新的對照品目錄并檢查是否

5、現(xiàn)行批號。Onreceiptofreferencestandards,checkwhetherthelotiscurrentornotfromthelatestcatalogsdownloadedfromfollowingwebsites:- USP對照品ForUSPRS:- EP對照品ForEPCRS:- BP對照品ForBPCRS:www.bpclab.co.uk- Ch.P對照品ForCh.PRS:5.1.3 檢查瓶子包裝應(yīng)完好無損，標簽正確無誤。Thevialshouldbecheckedforintactnessandcorrectne

6、ssoflabel.5.1.4 接收情況應(yīng)在附件-I中所示的對照品接收記錄中記錄Thereceiptshouldberecordedinhe'ReferenceStandardsReceiptRecord'aAnnexure-I.5.1.5 對照品序號應(yīng)作為內(nèi)部編碼并用以使用情況追溯。TheserialnumbershouldbetreatedasIn-houseidentificationnumberandshouldbeusedforreferencepurpose.5.1.6 任何相關(guān)資料、包裝的完好無損、現(xiàn)行批號狀況和有效期(如果有)應(yīng)記錄在備注欄中。Receiptof

7、anyliterature,intactnessofvial,currentlotstatusandexpirydate(Ifapplicable)shouldberecordedintheremarkcolumn.5.1.7 所有對照品應(yīng)按藥典機構(gòu)在標簽上或個別文件中描述的儲存條件進行儲存。Allreferencestandardsshouldbestoredatstorageconditionsasprescribedbythepharmacopoiealagencyonthelabelorinrespectivedocuments.5.1.8 如果接收的同一種對照品不止一瓶，則只能發(fā)放一

8、瓶在使用記錄中登記并使用(如附件-II所示)。Ifmorethanonevialofthesamereferencestandardisreceived,onlyonevialandusagerecord(AsperAnnexure-II)shouldbeissuedforuse.5.1.9 同種對照品的剩余瓶數(shù)應(yīng)儲存并收藏起來，前一瓶使用完后，接著再發(fā)放下一瓶，并在如附件-II所示的對照品使用記錄中登記。Remainingvialsshouldbemaintainedasstockandafterconsumptionofpreviousvial,nextvialofsamereferenc

9、estandardand'referencestandardusagere(perAnnexure-IIcouldbeissuedforuse.5.2 對照品的使用Useofreferencestandards制定人Preparedby審核人Reviewedby批準人Approvedby簽名/日期Sign/Date名字Name職務(wù)Designation標題：藥典對照品的接收、儲存、使用和保管程序TITLE:PROCEDUREFORRECEIPT,STORAGE,USEANDMAINTENANCEOFPHARMACOPOIEALREFERENCESTANDARD5.2.1 確保對照品批號

10、是現(xiàn)行有效的批號，并且瓶中無異常情況。Ensurethereferencestandardisofcurrentlotandthereisnoabnormalityinthevial.5.2.2 使用對照品應(yīng)注意避免所有污染和溢出。Takeallnecessaryprecautionstoavoidanycontaminationandspillageduringusingthereferencestandards.5.2.3 打開瓶子前確保放置區(qū)域清潔且無以前樣品的殘留。Ensuretheareaiscleanandfreefromtracesofpreviousproductsbefore

11、openingthevial.5.2.4 冰箱儲存的對照品使用前應(yīng)放在干燥器中升到室溫。Refrigeratedvialsshouldbeallowedtoequilibratetoroomtemperaturebykeepingthemindesiccatorsbeforeuse.5.2.5 打開瓶子，只取出要求數(shù)量的對照品，取出的剩余對照品應(yīng)丟棄，不得倒回瓶中。Openthevialandtakeonlyrequiredquantityofmaterial,remainingremovedmaterialshouldbediscardedandshouldnotpourbacktothev

12、ial.5.2.6 使用完畢立即蓋緊瓶蓋并在瓶頸周圍繞上封口膜。Immediatelyafteruse,closethevialwithoriginalcapandwrapPara-filmaroundtheneckofthevial.5.2.7 分別按各自儲存條件儲存對照品。Storethevialtorespectivestoragecondition.5.2.8 在附件-II所示的對照品使用記錄中登記。Anentryfortheusageshouldbemadeinthe'ReferenceStandardUsageRecordasperAnnexure-II.5.3 對照品的保

13、管Maintenanceofreferencestandards5.3.1 應(yīng)對照現(xiàn)行對照品目錄檢查現(xiàn)有對照品。(參照”5.1接收和儲存”中下載的現(xiàn)行對照品目錄)。Currentlotofreferencestandardsshouldbecheckedagainstcurrentcatalogs.(Refer5.1Receiptandstorage'fordownloadingthecurrentcatalogs).5.3.2每月的第一周應(yīng)檢查對照品的儲存情況，所有失效或用完的瓶子應(yīng)從儲存處移除并銷毀。制定人Preparedby審核人Reviewedby批準人Approvedby簽名

14、/日期Sign/Date名字Name職務(wù)Designation標題：藥典對照品的接收、儲存、使用和保管程序TITLE:PROCEDUREFORRECEIPT,STORAGE,USEANDMAINTENANCEOFPHARMACOPOIEALREFERENCESTANDARDFirstweekofeverymonth,stockofreferencestandardsshouldbereviewedandanyexpired/exhaustedvialshouldberemovedfromthestockandshouldbedestroyed.5.3.3應(yīng)按附件-II所示的對照品使用記錄中記錄

15、銷毀情況。Entryfordestructionshouldbemadein'ReferenceStandardUsageRecord'aAnnexure-II.6.1 相關(guān)文件RelatedDocuments:6.1 對照品接收記錄(附表-I)REFERENCESTANDARDSRECEIPTRECORD(Annexure-I)6.2 對照品使用記錄(附表-II)REFERENCESTANDARDUSAGERECORD(Annexure-II)6.2 修訂記錄RevisionRecord：廳pSl.No版本號RevisionStatus修訂內(nèi)容DetailsofRevisio

16、n備注Remarks*文件終結(jié)符ENDOFDOCUMENT制定人Preparedby審核人Reviewedby批準人Approvedby簽名/日期Sign/Date名字Name職務(wù)Designation附表-IANNEXURE-I對照品接收記錄REFERENCESTANDARDSRECEIPTRECORD參照文件編碼Doc.Ref.No.:表格號FormNo.:生效日期EffectiveDate:第1頁共1頁page1of1廳pS.No.接收日期DateofReceipt對照品名稱ReferenceStandardName對照品來源Source批號LotNo.儲存條件StorageCondition接收數(shù)量QuantityReceived接收人Receivedby備注Remark制定人Preparedby審核人Reviewedby批準人Approvedby簽名/日期Sign/Date名字Name職務(wù)Designation附件-IIANNEXURE-II對照品使用記錄REFERENCESTANDARDUSAGERECORD參照文件編碼Doc.Ref.No.:表格號FormNo.:生效日期EffectiveDate:第1頁共1頁page1of1對照品名稱NameofReferenceStandards:批號LotN