eugmp指南附件8：起始物料和包装材料的取样(中英文)

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1、EUGMP指南附件8：起始物料和包装材料的取样（中英文）Annex8附件8SAMPLINGOFSTARTINGANDPACKAGINGMATERIALS起始物料和包装材料的取样Principle原则Samplingisanimportantoperationinwhichonlyasmallfractionofabatchistaken.Validconclusionsonthewholecannotbebasedontestswhichhavebeencarriedoutonnonrepresent

2、ativesamples.CorrectsamplingisthusanessentialpartofasystemofQualityAssuranee.収样是一个重要的操作，取样中，每批仅有小部分被収出。如果対不具有代表性的样品进行检测，则不能得出有效结论。因而正确的取样方法是质量保证体系的必要因素。Note注SamplingisdealtwithinChapter6oftheGuide,items6.11.to6.14.Thisannexgivesadditionalguidanceonthesa

3、mplingofstartingandpackagingmaterials.取样在指南第6章第6.11至6.14项。本附件针对起始物料和包装物料给出一些额外的指南。Personnel人员1.Personnelwhotakesamplesshouldreceiveinitialandon-goingregulartraininginthedisciplinesrelevanttocorrectsampling.Thistrainingshouldinelude:収样人员应接受与正确取样操作和关的初始培训

4、和周期性继续再培训，该培训应包括：—samplingplans,—収样计划—writtensamplingprocedures,—书面取样程序—thetechniquesandequipmentforsampling,一取样技术和取样工具—therisksofcross-contamination,—交叉污染风险——theprecautionstobetakenwithregardtounstableand/orsterilesubstances,—対不稳定和/或无菌物料采取的预防措施—theimpo

5、rtsneeofconsideringthevisualappearsneeofmaterials,containersandlabels,考察物料、包材和标签的外观的重要性—theimportanceofrecordinganyunexpectedorunusualcircumstances・—记录非预期或界常情况的重耍性Startingmaterials起始物料1.Theidentityofacompletebatchofstartingmaterialscannormallyonlybeensu

6、redifindividualsamplesaretakenfromallthecontainersandanidentitytestperformedoneachsample.Itispermissibletosampleonlyaproportionofthecontainerswhereavalidatedprocedurehasbeenestablishedtoensurethatnosinglecontainerofstartingmaterialhasbeenincorrectlylabe

7、lled.为保证起始物料一个完整批准的鉴别，一般需要对每个包装进行单独収样，独立检测鉴别项。如果建立有经过验证的程序，保证不会有单个包装标签错课情况发牛，则允许对部分包装进行取样。3・Thisvalidationshouldtakeaccountofatleastthefollowingaspects:本验i正需要考虑至少以下方面—thenatureandstatusofthemanufacturerandofthesupplierandtheirunderstandingoftheGMPrequir

8、ementsofthePharmaceuticalIndustry;—牛•产商和供应商的具体情况和状态，及其对制药行业GMP要求的理解—theQualityAssuraneesystemofthemanufacturerofthestartingmaterial;—起始物料生产商的质量保证体系—themanufacturingconditionsunderwhichthestartingmaterialisproducedandcontrolled;—起