who -TRS 1052 - Annex 2 - WHO good manufacturing practices for excipients used in pharmaceutical products-此为英文文档31.docx

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who -TRS 1052 - Annex 2 - WHO good manufacturing practices for excipients used in pharmaceutical products-此为英文文档31.docx

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综上所述，该文档的主要内容集中在WHOGoodManufacturingPracticesGMPS的相关规定方面，强调了在制造制药产品过程中应注意的有害物质对药品质量的影响，并提出了一些建议来提高产品的质量和安全性的方法同时，作者还建议制造商应能够识别并管理生产过程中的风险，包括原料来源的选择工艺路线的选择以及最终产品的检验流程

Annex2

WHOgoodmanufacturingpracticesforexcipientsusedinpharmaceuticalproducts

Background

TheWHOguidelineGoodmanufacturingpractices:supplementaryguidelinesforthemanufactureofpharmaceuticalexcipientswaspublishedintheWHOTechnicalReportSeriesNo.885,Annex5,1999.

Asexcipientsaresometimesusedinlargequantitiesinpharmaceuticaldosageforms,andmaycontainimpurities,theycanaffectthequalityofafinishedpharmaceuticalproduct.

Themanufacturerofthefinishedpharmaceuticalproductisnormallydependentontheexcipientmanufacturertosupplyexcipientsmeetingtherequiredspecification.Anappropriatelyestablishedandimplementedqualitymanagementsystemevaluatingandcontrollingrisksintheproductionandqualitycontrolofsuchexcipientsisthereforerequired.

Excipientmanufacturersshouldberequiredtoapplytheappropriateprinciplesofgoodmanufacturingpractices(GMPs)inproducingpharmaceuticalexcipients.Reportsofpharmaceuticalproductsthatcontaincontaminatedexcipients,orexcipientswithimpuritiesleadingtothedeathofpatients,havefurtherhighlightedtheimportanceofreviewingtheoriginalguideline.Furthermore,theconceptofongoingimprovement,thelifecycleapproach,betterqualitymanagementsystems,riskmanagement,andmanagementreviewshouldbedescribedinsuchaguideline,alongsidethenecessarygoodstorage,goodtradeandgooddistributionpractices,toensurequalitythroughoutthesupplychain,asapplicable.

Themanufacturerofexcipientsusedinpharmaceuticalproductsshouldbeabletoidentifyrisksassociatedwiththeproduction(includingstagesofmanufacturing,routeofsynthesis)andqualitycontrolofitsproducts.Thisincludesthepremises,equipment,utilities,storageanddistribution.Themanufacturerofsuchexcipientsshouldassessthoserisksandidentifyappropriatemeasurestomitigate