CGMP文件 工作對(duì)照品雜質(zhì)對(duì)照品的接收處理保管標(biāo)準(zhǔn)程序SOP

本文格式為Word版，下載可任意編輯——CGMP文件工作對(duì)照品雜質(zhì)對(duì)照品的接收處理保管標(biāo)準(zhǔn)程序SOP生效日期：EffectiveDate:復(fù)審日期：ReviewDate:替代：Supersedes:頁(yè)碼：第1頁(yè)共5頁(yè)P(yáng)ageNo.:1of5標(biāo)題：工作對(duì)照品/對(duì)照品/雜質(zhì)對(duì)照品的接收、處理和保管標(biāo)準(zhǔn)程序TITLE:RECEIPT,HANDLINGANDMAINTENANCEOFWORKING/REFERENCEANDIMPURITYSTANDARD標(biāo)準(zhǔn)操作程序StandardOperatingProcedure文件編碼Doc.No.:頒發(fā)日期：IssueDate:1.0目的Purpose:描述工作對(duì)照品/對(duì)照品/雜質(zhì)對(duì)照品的接收、處理和保管的標(biāo)準(zhǔn)程序

Tolaydownaprocedureforreceipt,handlingandmaintenanceofworkingstandard/referencestandardandimpurities.

2.0范圍Scope:本程序適用于工作對(duì)照品/對(duì)照品/雜質(zhì)對(duì)照品的接收、處理和保管。這些對(duì)照品來(lái)自研發(fā)部門(mén)和外部原料藥生產(chǎn)商。

Thisprocedureisapplicableforreceipt,handlingandmaintenanceofworking

standard/referencestandardandimpuritiesreceivedfromR&D&ExternalAPIvendor.

3.04.0

定義Definitions:無(wú)Nil責(zé)任Responsibility:

所有的QC人員有責(zé)任在他們的崗位上遵循此標(biāo)準(zhǔn)操作程序的操作。

AllQCpersonalareresponsibleforfollowingthisSOPaspertheirrespectiveroles.

5.0程序Procedure5.1

接收Receipt:

5.1.1在接收的時(shí)候，檢查是否有檢驗(yàn)報(bào)告單（COA）和支持性數(shù)據(jù)。若沒(méi)有，

則向廠家索取。檢查容器是否完好無(wú)損，對(duì)比COA和標(biāo)簽的內(nèi)容。Atthetimeofreceipt,checktheavailabilityofCertificateofAnalysis(COA)andsupportingdata.Ifnot,thenaskthesourcetoprovidethem.ChecktheintactnessofcontainersandcomparethecontentsofCOAandlabel.

5.1.2假使發(fā)現(xiàn)不符合之處，跟生產(chǎn)商聯(lián)系來(lái)更正它。

Ifanydiscrepancyisobserved,thencontactsuppliertocorrectthem.5.1.3依照附錄-I的要求記錄每個(gè)工作對(duì)照品/對(duì)照品/雜質(zhì)對(duì)照品的接收細(xì)節(jié)。

Recordthereceiptdetailsofeachworkingstandard/referencestandardandimpuritiesasperAnnexure-I.5.1.4接收的序號(hào)應(yīng)被視為工作對(duì)照品/對(duì)照品/雜質(zhì)對(duì)照品的內(nèi)部編碼。簽名/日期Sign/Date名字Name職務(wù)Designation

制定人Preparedby審核人Reviewedby批準(zhǔn)人ApprovedbyPageNo.:2of5文件編碼Doc.No.:標(biāo)題：工作對(duì)照品/對(duì)照品/雜質(zhì)對(duì)照品的接收、處理和保管標(biāo)準(zhǔn)程序TITLE:RECEIPT,HANDLINGANDMAINTENANCEOFWORKING/REFERENCEANDIMPURITYSTANDARDTheserialnumberofreceiptshouldbetreatedasIn-houseIDofworkingstandard/referencestandardandimpurities.

5.1.5在COA上注明內(nèi)部編碼，把所有的COA按內(nèi)部編碼的順序放在單獨(dú)的文

件夾里。

MentionIn-houseIDontheCOAandkeepallCOAinaseparatefileasperIn-houseID.5.1.6關(guān)于原料藥的工作對(duì)照品/對(duì)照品，檢查一下COA和標(biāo)簽上是否折算過(guò)的

含量。假使沒(méi)有，用下面的公式，依據(jù)附錄-II,計(jì)算折算后的含量。

Forworking/referencestandardforAPI,checkifthepotencyon‘a(chǎn)s-is-basis’isavailableonCOAandlabel.Ifnot,calculatethepotencyon‘a(chǎn)s-is-basis’usingfollowingformulaasperAnnexure-II.

5.2

公式Formula:

5.2.1假使含量是按無(wú)水物/枯燥品計(jì)算

Iftheassayisonanhydrous/driedbasis折算后的含量(%w/w)：

Potencyof‘a(chǎn)s-is-basis’(%w/w):

按無(wú)水物/枯燥品計(jì)算的含量(%w/w)×(100-KF水分%/枯燥失重%)100

Assayonanhydrous/driedbasis(%w/w)X(100-%WaterbyKF/LOD)100

5.2.2假使含量是按無(wú)水物/枯燥品和無(wú)溶劑物計(jì)算

Iftheassayisonanhydrous/driedandsolventfreebasis折算后的含量

Potencyof‘a(chǎn)s-is-basis’(%w/w)：

按無(wú)水物/枯燥品計(jì)算的含量(%w/w)×(100-KF水分%/)×（100-溶劑%）100X100

Assayonanhydrous/driedbasis(%w/w)X(100-%WaterbyKF/LOD)X(100-%Solvent)100X100

5.2.3將附錄-II附在接收的COA后。

AttachAnnexure-IItotheCOAreceived5.2.4給小瓶貼上含有下面信息的中文標(biāo)簽。

簽名/日期Sign/Date名字Name職務(wù)Designation

制定人Preparedby審核人Reviewedby批準(zhǔn)人ApprovedbyPageNo.:3of5文件編碼Doc.No.:標(biāo)題：工作對(duì)照品/對(duì)照品/雜質(zhì)對(duì)照品的接收、處理和保管標(biāo)準(zhǔn)程序TITLE:RECEIPT,HANDLINGANDMAINTENANCEOFWORKING/REFERENCEANDIMPURITYSTANDARDLabelthevialsinChineselanguagewithfollowingdetailsonthelabel:-------

產(chǎn)品名稱(chēng)NameofProduct批號(hào)Batch/LotNumber內(nèi)部編碼In-houseID

折算含量Potencyon‘a(chǎn)s-is-basis’生產(chǎn)日期ManufacturingDate復(fù)測(cè)日期RetestDate

儲(chǔ)存條件StorageCondition

5.2.5每個(gè)接收的對(duì)照品依照附錄-III做好“工作對(duì)照品/雜質(zhì)對(duì)照品使用記

錄〞。

Issue‘Working/ImpurityStandardUsageRecord’asperAnnexure-IIIforeachitemreceived.

5.2.6假使一致雜質(zhì)/工作對(duì)照品多于一個(gè)小瓶，只能先使用一個(gè)。

Ifmorethanonevialofsameimpurity/workingstandardisavailable,onlyonevialshouldbeissuedforuse.5.2.7剩余的小瓶應(yīng)當(dāng)作為庫(kù)存，在前一個(gè)小瓶消耗完后，再分發(fā)使用。

Remainingvialsshouldbemaintainedasstockandshouldbeissuedaftertheconsumptionofpreviousvial.

5.3

處理Handling

5.3.1確保對(duì)照品是有效的，還沒(méi)過(guò)期。

Ensurethatthestandardisvalidandhasnotexpired.

5.3.2冰箱中的小瓶存放在枯燥器中，恢復(fù)到室溫。

Refrigeratedvialsshouldbebroughttoroomtemperaturebykeepingindesiccator.5.3.3在確定工作區(qū)域是清白的，并且沒(méi)有前面的污染后，再開(kāi)啟工作對(duì)照品的

小瓶。

Opentheworkingstandardvialafterensuringthattheworkingareaiscleanandfreefrompreviouscontamination.5.3.4從小瓶中取出需要的數(shù)量，假使取出的數(shù)量過(guò)多，不要把多余的放回去，

丟掉多余的。

Removeonlyrequiredquantityfromthevial,ifexcessquantityisremoved,thendonotputitbacktovial,discardtheexcessmaterial.簽名/日期Sign/Date名字Name職務(wù)Designation

制定人Preparedby審核人Reviewedby批準(zhǔn)人ApprovedbyPageNo.:4of5文件編碼Doc.No.:標(biāo)題：工作對(duì)照品/對(duì)照品/雜質(zhì)對(duì)照品的接收、處理和保管標(biāo)準(zhǔn)程序TITLE:RECEIPT,HANDLINGANDMAINTENANCEOFWORKING/REFERENCEANDIMPURITYSTANDARD5.3.5使用完后，立刻蓋緊瓶子，恢復(fù)各自的儲(chǔ)存條件。

Afteruse,immediatelyclosethevialandreturntotherespectivestoragecondition.5.3.6每個(gè)分發(fā)的小瓶依照附錄-III記錄分發(fā)狀況。

RecordthedetailsasperAnnexure-IIIissuedfortheparticularvial.

5.4

保管Maintenance

5.4.1移走過(guò)期的小瓶。

Removeexpiredvialsfromtheuse.

5.4.2提前取得新對(duì)照品，取代過(guò)期的對(duì)照品。

Procurenewstandardtoreplacetheexpiredstandardwellinadvance.

6.0

相關(guān)文件RelatedDocuments:6.16.2

外來(lái)工作對(duì)照品/雜質(zhì)對(duì)照品接收記錄（附件-I）

WORKING/IMPURITYSTANDARDSRECEIPTRECORD(ANNEXURE-I)從外部接收的工作對(duì)照品的含量計(jì)算記錄（附件-II）

POTENCYCALCULATIONOFWORKINGSTANDARDRECEIVEDFROMOTHERLACATIONS(ANNEXURE-II)

外來(lái)工作對(duì)照品/雜質(zhì)對(duì)照品使用記錄（附件-III）

WORKING/IMPURITYSTANDARDUSAGERECORD(ANNEXURE-III)

6.3

7.0修訂記錄RevisionRecord:序號(hào)版本號(hào)Sl.NoRevisionStatus修訂內(nèi)容DetailsofRevision備注Remarks******文件終止符ENDOFDOCUMENT

簽名/日期Sign/Date名字Name職務(wù)Designation

制定人Preparedby審核人Reviewedby批準(zhǔn)人Approvedby

附表-IANNEXURE-I外來(lái)工作對(duì)照品/雜質(zhì)對(duì)照品接收記錄

WORKING/IMPURITYSTANDARDSRECEIPTRECORD參照文件編碼Doc.Ref.No.:表格號(hào)FormNo.:

生效日期EffectiveDate:第1頁(yè)共1頁(yè)page1of1儲(chǔ)存條件接收數(shù)量序號(hào)接收日期品名對(duì)照品來(lái)源批號(hào)StorageQuantityS.No.DateofReceiptNameSourceLotNo.ConditionReceived接收人備注ReceivedRemarkby簽名/日期Sign/Date名字Name職務(wù)Designation

制定人Preparedby審核人Reviewedby批準(zhǔn)人Approvedby

附件-IIANNEXURE-II從外部接收的工作對(duì)照品的含量計(jì)算記錄

POTENCYCALCULATIONOFWORKINGSTANDARDRECEIVEDFROMOTHERLACATIONS參照文件編碼Doc.Ref.No.:表格號(hào)FormNo.:

生效日期EffectiveDate:第1頁(yè)共1頁(yè)page1of1從外部接收的工作對(duì)照品的含量計(jì)算記錄POTENCYCALCULATIONOFWORKINGSTANDARDRECEIVEDFROMOTHERLACATIONS工作對(duì)照品名稱(chēng)NameofWorkingStandard:工作對(duì)照品批號(hào)B.No./LotNo.ofWorkingStandard:工作對(duì)照品內(nèi)部編碼In-houseIDofWorkingStandard:含量%，按無(wú)水物/枯燥品計(jì)%w/wAssayonanhydrous/driedbasis:含量%，按無(wú)水物/枯燥品和無(wú)溶劑物計(jì)%w/wAssayonanhydrous/driedandsolventfreebasis:水分%/枯燥失重%%Watercontent/Lossondrying:殘留溶劑含量%%solventcontents:折算后的含量Assay/Potencyonasisbasis:________________________________計(jì)算人（簽名/日期）復(fù)核人（簽名/日期）Calculatedby:CheckedBy:(Sign/date)(Sign/da