需要金币:*** 金币(10金币=人民币1元) WHO制药用水GMP指南-2020.pdf 关闭预览 想预览更多内容,点击免费在线预览全文 免费在线预览全文 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 Sabi...
WHO TRS986 附录 2:WHO 药品 GMP 总则, 2014.pdf,Annex 2 WHO good manufacturing practices for pharmaceutical products: main principles1 Introduction 79 General considerations 80 Glossary 81 Quality management in the medicines industry: philosophy and esse
2012年秘书处意识到现有药品GMP总则(附录3WHO技术系列文件,No.961,2011)需要更新?Qualityassuranceofpharmaceuticals:acompendiumofguidelinesandrelatedmaterials).世界卫生组织专家委员会在48次专家会议上讨论了关于药品制备说明更新的必要性,并同意执行。经过日常商讨后,以下为最新的版本修订的部分,并在第48次专家会议上...
WHO最新指南:《药品生产技术转移指南》(中英文对照)-202011.pdf,WHO 最新指南:《药品生产技术转移指南》(中英文对照) PharmLink 指南组 12 月 4 日,世界卫生组织(WHO )于发布《药品生产技术转移指南》 (WHO guidelines on the transfer of technology in pharmaceu
1.2. The objective of this update is tobring the guideline in line with current expectations and trends in goodmanufacturing practices and to harmonize the text with the principles fromother related international guidelines.本次更新的目的是使得指南与当前 GMP 要求和趋势相一致,并在内容上与其它相关...
WHO 数据完整性指南-2021(中英文对照)02版.pdf,WHO 技术报告No.1033 附录4 数据完整性指南-2021 GMP 办公室翻译组翻译 Annex 4 附录4 Guideline on data integrity 数据完整性指南 This document replaces the WHOGuidance on good data and record management practices
12月4日,世界卫生组织(WHO)于发布《药品生产技术转移指南》(WHO guidelines on the transfer of technology in pharmaceutical manufacturing),提供了药品技术转让期间应考虑的指导原则。 本指南主体部分分为12个章节,内容如下: 背景 1.简介 2.范围 3.术语 ...
WHO无菌药品GMP2011版 下载积分:2000 内容提示: 261© World Health OrganizationWHO Technical Report Series, No. 961, 2011Annex 6WHO good manufacturing practices for sterile pharmaceutical products IntroductionFollowing implementation of these WHO good manufacturing practices (GMP) guidelines (1) within ...
The WHO provides GMP guidelines and also offers a program of GMP compliance certification. One of the most valuable document is the WHO Technical Report 908, which is available at http://whqlibdoc.who.int/trs/WHO_TRS_908.pdf#page=46 . In addition, the WHO offers many very useful GMP ...
良好生产规范(GMP) 质量保证的一部分,可确保始终如一地生产和控制药品,达到适合其预期用途的质量标准,并符合上市许可要求。 in-process control (IPC). Checks performed during production in order to monitor and, if necessary, to adjust the p...