ANNE 19 Reference and Retention Samples WZH 20060906分析和总结分析和总结.docxVIP

Annex19 附件19

ReferenceandRetentionSamples

标准样品和留样

Scope范围

ThisAnnextotheGuidetoGoodManufacturingPracticeforMedicinalProducts(“theGMPGuide”)givesguidanceonthetakingandholdingofreferencesamplesofstartingmaterials,packagingmaterialsorfinishedproductsandretentionsamplesoffinishedproducts.

药品标准生产规范指南（GMP指南）的本附件给出了起始原料，包装材料，以及最终产品的标准样品的获取和保存以及最终产品留样原则。

SpecificrequirementsforinvestigationalmedicinalproductsaregiveninAnnex13totheGuide.

研究用药物产品的特殊要求在附件13中给出。

Thisannexalsoincludesguidanceonthetakingofretentionsamplesforparallelimported/distributedmedicinalproducts.

1.3本附件也包括相应进口分发药物产品的取样留样指导。

Principle原则

Samplesareretainedtofulfiltwopurposes;firstlytoprovideasampleforanalyticaltestingandsecondlytoprovideaspecimenofthefullyfinishedproduct.Samplesmaythereforefallintotwocategories:

留样有以下两个目的：首先为分析检验提供样品，其次提供完全终产品的留样。因此样品应分为以下两类：

Referencesample:asampleofabatchofstartingmaterial,packagingmaterialorfinishedproductwhichisstoredforthepurposeofbeinganalysedshouldtheneedariseduringtheshelflifeofthebatchconcerned.Wherestabilitypermits,referencesamplesfromcriticalintermediatestages(e.g.thoserequiringanalyticaltestingandrelease)orintermediates,thataretransportedoutsideofthemanufacturer’scontrol,shouldbekept.

标准样品：起始原料、包装材料或终产品的一批样品，留样用于在该批产品上市有限期可能出现的的分析需要。如果稳定性允许，关键中间步骤（例如需要分析检验放行的步骤）样品，或者运输到生产者控制范围外的中间体，也应留样。

Retentionsample:asampleofafullypackagedunitfromabatchoffinishedproduct.Itisstoredforidentificationpurposes.Forexample,presentation,packaging,labelling,patientinformationleaflet,batchnumber,expirydateshouldtheneedariseduringtheshelflifeofthebatchconcerned.Theremaybeexceptionalcircumstanceswherethisrequirementcanbemetwithoutretentionofduplicatesamplese.g.wheresmallamountsofabatcharepackagedfordifferentmarketsorintheproductionofver