forHarmonisationofTechnicalRequirementsfor 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。 1.8Thisversionofthegu...
manufacturingpractices(GMP)forpharmaceuticalproducts:mainprinciples, publishedasAnnex3intheWHOTechnicalReportSeries,No.961,2011, would needupdating(/medicines/areas/quality_safety/quality_ assurance/production/en/index.html−Qualityassuranceofpharmaceuticals: acompendiumofguidelinesandrelatedmaterials). TheWHOExpert...
JULIA 译文供供参考 页 1 / 37 DRAFT WORKING DOCUMENT FOR COMMENTS : WHO guidelines on the transfer of technology in pharmaceutical manufacturing WHO 药品生产技术转移指南 (草稿) Please send your comments to Dr Sabine Kopp, Team Lead, Norms and Standards for Pharmaceuticals, Technical Standards and ...
/teams/health-product-and-policy-standards/standards-and-specifications/norms-and- standards-for-pharmaceuticals/guidelines/quality-assurance. 药物和剂型在每个部分中按字母顺序列出,上市的顺序并不意味着更倾向于一种形式而不是优先于另一 种形式。应咨询标准的治疗指南,以了解适当的剂量型。 基本药物清单中用于...
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
10、tices for pharmaceuticals (WHO TRS, No. 908, Annex 5) WHO guidelines for sampling of pharmaceutical products and related materials (WHO TRS, No. 929, Annex 5)一、WHO预认证简介二、二、WHO GPCL简介简介三、中检院化学药品实验室预认证情况四、WHO预认证及药品抽验相关实验室区域间研讨会五、全国...
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...
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 Pharmaceutica...
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 and Specifications (kopps@who.int), with...
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...