EUGMP指南附件8：起始物料和包装材料的取样(中英文)

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 原贝 USamplingisanimportantoperationinwhichonlyasmallfractionofabatchistaken.Validconclusionsonthewholecannotbebasedontestswhichhavebeencarriedoutonnonrepresentativesamples.Correctsamplingisthusanesse

2、ntialpartofasystemofQualityAssurance.取样是一个重要的操作，取样中，每批仅有小部分被取出。如果对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.Thisannexgivesadditionalguidanceonthesamplingofstartingandpackagingmaterials.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

3、南。Personnel 人员1.Personnelwhotakesamplesshouldreceiveinitialandon-goingregulartraininginthedisciplinesrelevanttocorrectsampling.Thistrainingshouldinclude:取样人员应接受与正确取样操作相关的初始培训和周期性继续再培训，该培训应包括：-samplingplans,一取样计划-writtensamplingprocedures,一书面取样程序-thetechniquesandequipmentforsampling,一取样技术和取样工具-theris

4、ksofcross-contamination,一交叉污染风险-theprecautionstobetakenwithregardtounstableand/orsterilesubstances,一对不稳定和/或无菌物料采取的预防措施-theimportanceofconsideringthevisualappearanceofmaterials,containersandlabels,一考察物料、包材和标签的外观的重要性-theimportanceofrecordinganyunexpectedorunusualcircumstances.-记录非预期或异常情况的重要性Startingma

5、terials 起始物料2.Theidentityofacompletebatchofstartingmaterialscannormallyonlybeensuredifindividualsamplesaretakenfromallthecontainersandanidentitytestperformedoneachsample.Itispermissibletosampleonlyaproportionofthecontainerswhereavalidatedprocedurehasbeenestablishedtoensurethatnosinglecontainerofstar

6、tingmaterialhasbeenincorrectlylabelled.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取样，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误情况发生，则允许对部分包装进行取样。3.Thisvalidationshouldtakeaccountofatleastthefollowingaspects:本验证需要考虑至少以下方面-thenatureandstatusofthemanufacturerandofthesupplierandtheirunderstandingoftheGMPrequirementsofthePha

7、rmaceuticalIndustry;一生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-theQualityAssurancesystemofthemanufacturerofthestartingmaterial;一起始物料生产商的质量保证体系-themanufacturingconditionsunderwhichthestartingmaterialisproducedandcontrolled;一起始物料的生产受到控制-thenatureofthestartingmaterialandthemedicinalproductsinwhichitwillbeused.

8、一起始物料的属性和使用该起始物料的药品的属性Undersuchasystem,itispossiblethatavalidatedprocedureexemptingidentitytestingofeachincomingcontainerofstartingmaterialcouldbeacceptedfor:在这种体系下，可能需要一个验证过的程序，以免除对以下起始物料每个进厂包装的鉴别实验-startingmaterialscomingfromasingleproductmanufacturerorplant;一起始物料来自于一个仅生产一个产品的生产商或工厂-startingmateri

9、alscomingdirectlyfromamanufacturerorinthemanufacturerssealedcontainerwherethereisahistoryofreliabilityandregularauditsofthemanufacturerQualityAssurancesystemareconductedbythepurchaser(themanufacturerofthemedicinalproduct)orbyanofficiallyaccreditedbody.一起始物料从生产商处直接送来，或采用生产商的封装容器，有历史数据证明其可靠性，或由采购方(药品生

10、产商)或官方授信主体对生产商的质量保证体系进行常规审计Itisimprobablethataprocedurecouldbesatisfactorilyvalidatedfor:对以下情况，则不可能得到一个满意的验证结果-startingmaterialssuppliedbyintermediariessuchasbrokerswherethesourceofmanufactureisunknownornotaudited;一由中间商供应的起始物料，如贸易商，该物料的生产商为未知或未经审计-startingmaterialsforuseinparenteralproducts.一用于注射用药生

11、产的起始物料4.Thequalityofabatchofstartingmaterialsmaybeassessedbytakingandtestingarepresentativesample.Thesamplestakenforidentitytestingcouldbeusedforthispurpose.Thenumberofsamplestakenforthepreparationofarepresentativesampleshouldbedeterminedstatisticallyandspecifiedinasamplingplan.Thenumberofindividual

12、sampleswhichmaybeblendedtoformacompositesampleshouldalsobedefined,takingintoaccountthenatureofthematerial,knowledgeofthesupplierandthehomogeneityofthecompositesample.通过采取具有代表性的样品进行检测，可以对起始物料的批质量进行评估。鉴别用样品可以用于此目的。用于具有代表性的样品制备的样品数量可以基于统计学数据，并在取样计划中列明。可以用于制备混合样的单个样品数量也应该指定，指定时应考虑物料的特性、对供应商的了解和混合样的均一性。P

13、ackagingmaterial 包装材料5.Thesamplingplanforpackagingmaterialsshouldtakeaccountofatleastthefollowing:thequantityreceived,thequalityrequired,thenatureofthematerial(e.g.primarypackagingmaterialsand/orprintedpackagingmaterials),theproductionmethods,andwhatisknownoftheQualityAssurancesystemofthepackagingmaterialsmanuf