Annex 16 of the EU GMP guideline gives guidance in relation to situations where different stages of manufacture of a batch take place at different manufacturing sites. 欧盟GMP指南附件16对于同一批次的不同生产阶段在不同生产地点进行的情况提供了指导。 In such cases, the overall responsibility for c...
本文件提供了指令 2003/94/EC 中所规定的人用药品和指令 91/412/EEC 中的兽药优良生产规范(GMP)的解释指南。 Status of the document: Revision. 文件状态:修订 Reasons for changes: The Annex has been revised to reflect the globalisation of the pharmaceutical supply chains and the introduction of new ...
1.5.1 The process of certification as described in Section 1 of this Annex, applies to all medicinal products intended to be released for the EU markets, or for export, irrespective of the complexity of the supply chain and the global locations of manufacturing sites involved. 1 1.2. 1.3. ...
这只是与EU GMP指南新附录16(QP声明和批放行)相关的常见问题中的两个例子而已。 The new Annex came into force in April 2016 with quite a few new requirements and expectations. And it is still causing some uncertainty. Some of the major questions have now been answered in a blog of the U.K....
(GMP).Theprocessofbatchreleasecomprisesof:i.Thecheckingofthemanufactureandtestingofthebatchinaccordancewithdefinedreleaseprocedures.ii.ThecertificationofthefinishedproductbatchperformedbyaQPsignifyingthatthebatchisincompliancewithGMPandtherequirementsofitsMA.Thisrepresentsthequalityreleaseofthebatch.iii.Thetransferto...
EU-GMP-附录16:药品质量受权人签发证书与放行批产品-英文.doc,Scope This Annex provides guidance on the certification by a? \o 分类:质量受权人 Qualified Person?(QP) and on batch release within the European Union (EU) of medicinal products for human or veter
EU GMP 附录16:药品质量受权人签发证书和放行批产品-英文_药学_医药卫生_专业资料 Scope This Annex provides guidance on the certification by a Qualified Person (QP) and on batch release within the European Union (EU) of medicinal pr Scope This Annex provides guidance on the certification by a ...
ANNEX1附件1MANUFACTUREOFSTERILEMEDICINALPRODUCTS无菌医药产品的生产Principle原则Themanufactureofsterileproductsissubjecttospecialrequirementsinordertominimiserisksofmicrobiologicalcontaminationandofparticulateandpyrogencontamination.Muchdependsontheskillt
Annex16oftheEUGMPGuide,thePQRshouldincludean assessmentofthebasisforcontinuedrelianceonthissampling practice.PQRsshouldalsoincludeareviewofdeviationsrelatingto transportationuptothepointofbatchcertification.Specific requirementsforsamplingandtransportationofimportedproductsare detailedfurtherinAnnex16oftheEUGMPGuide. oAs...
EU-GMP指南第7章(外包活动)要求在委托活动之前“委托方有义务评估受托方成功执行外包活动的合法性、适当性以及其资格”【7.5】,并且“委托方应监管和审核受托方的表现(……)”【7.7】。 According to Annex 16 of the EU-GMP Guide, the QP has to ensure that "all audits of sites involved in the manufa...