manufacturingpractices(GMP)forpharmaceuticalproducts:mainprinciples, publishedasAnnex3intheWHOTechnicalReportSeries,No.961,2011, would needupdating(/medicines/areas/quality_safety/quality_ assurance/production/en/index.html−Qualityassuranceofpharmaceuticals: acompendiumofguidelinesandrelatedmaterials). TheWHOExpert...
附录2 WHO药品GMP指南_中英文_.pdf,Annex 2 WHO good manufacturing practices for pharmaceutical products: main principles 附录2 WHO药品GMP:主要原则 Introduction引言 General considerations总则 Glossary术语 Quality management in the medicines industry: philo
PharmaceuticalsforHumanUse(ICH)Q7,Q8,Q9,Q10andQ11. Thisguidelinedoesnotintendtoreplaceanyofthese guidelines. 应当结合参考文献(2-14)引用的其它WHO指南以及其它法规指南, 一起阅读本文档,其中包括ICHQ7,Q8,Q9,Q10和Q11。本指南 无意取代这些指南。 1.8Thisversionoftheguidelineprovidesupdatedrequirements andexpec...
961, 2011, annex 3 WHO 药品GMP 主要原理 控制的所有操作。 manufacturer 制造商 A company that carries out operations such as production, packaging, repackaging, labelling and relabelling of pharmaceuticals. 进行诸如药物生产、包装、重新包装、贴签和重新贴签操作的公司。 marketing authorization (product ...
WHO制药用水GMP指南-2020 下载积分:200 内容提示: Working document QAS/20.842 May 2020 DRAFT WORKING DOCUMENT FOR COMMENTS : Good manufacturing practices: water for pharmaceutical use Please send your comments to Dr Sabine Kopp, Team Lead, Norms and Standards for Pharmaceuticals, Technical Standards ...
957 Annex 1) WHO GMP: main principles for pharmaceutical products. In: Quality assurance of pharmaceuticals. A compendium of guidelines and related materials. Vol. 2, 2nd updated edition. Good manufacturing practices and inspection (Geneva, World Health Organization, 2007) Guidelines for p 9、...
_中英文_附录2 WHO药品GMP指南
《WHO制药生产技术转移指南( WHO guidelines on the transfer of technologyin pharmaceutical manufacturing)》,该指南解读及全文翻译如下: 1、要求转移方和接收方都应该有一个适当设计、明确定义和书面的质量体系。质量体系应具备足够的资源,充分实施和维护。 2、要求质量体系应包含GxP,不单单是GMP。 3、应保留技术...
1.7 This document should be read in conjunction with other WHO guidelines as referenced below (2-14), as well as other regulatory guidelines which include The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Q7, Q8, Q9, Q10 and Q11. This...
Working document QAS/20.869 WHO 制药生产技术转移指南（草案）GMP办公室翻译组 WHO guidelines on the transfer of technologyin pharmaceutical manufacturing WHO制药生产技术转移指南 Background 背景 1. Introduction 介绍 2. Scope 范围 3. Glossary 术语 4. Due diligence and gap assessments 尽职调查和差距评估...