WHO Technical Report Series, No. 970, 2012 Annex 2 附件2Page 1 of 20 Annex 2 附件2 WHO good manufacturing practices: water for pharmaceutical use WHO GMP：制药用水 1. Introduction 介绍 1.1 Scope of the document文件范围 1.2 Background to water requirements and uses 水的要求和使用背景...
WHOTechnicalReportSeries,No.970,2012Annex2附件2Page1of20 Annex2附件2 WHOgoodmanufacturingpractices:waterforpharmaceuticaluse WHOGMP:制药用水 1.Introduction介绍 1.1Scopeofthedocument文件范围 1.2Backgroundtowaterrequirementsanduses水的要求和使用背景
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用于既定用途所需质量的水应采用适当方法制备。 2. SCOPE范围 2.1. This document provides guidance for the production of Water for Injection (WFI) by means other than distillation. The principles may be applied to other qualities of water produced, meeting other specifications. 本文件提供非蒸馏方式注...
WHO_TRS_961 Annex2WHO药品微生物实验室管理规范 下载积分: 1000 内容提示: WHO 技术指南报告 No. 961, 2011, annex 2 WHO 药品微生物实验室管理规范 1 of 27 © World Health Organization 世界卫生组织 WHO Technical Report Series, No. 961, 2011 世界卫生组织技术报告系列,编号961 ,2011 年 Annex 2 ...
Geneva: World Health Organization; 2012: Annex 2 (WHO Technical Report Series, No. 970; https://apps.who.int/iris/bitstream/handle/10665/75168/ WHO_TRS_970.pdf?sequence=1 , accessed 29 July 2020). 2. WHO Good manufacturing practices for active pharmaceutical ingredients. In: WHO Expert ...
WHO《制药用水GMP指南》-2020草案(中英文对照版)Working document QAS/20.842 工作文件QAS/20.842 May 2020 二零二零年五月DRAFT WORKING DOCUMENT FOR COMMENTS:征求意见草案:Good manufacturing practices:优良制造规范（GMP）:water for pharmaceutical use 制药用水 1 / 25 ...
Validation of heating, ventilation and air-conditioning systems (as cross-reference to TRS 1010, Annex 8 (4))■ Appendix 2. Validation of water systems for pharmaceutical use (as published in TRS 937, Annex 4, 2006 and as cross-reference to TRS 970, Annex 2, 2012(5)■ Appendix 3. ...
12、WHO_TRS_981附录2:WHO质量风险管理指南-英-2013.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 Annex2 WHOguidelinesonqualityriskmanagement 1.Introduction62 1.1Backgroundandscope62 1.2Principlesofqualityriskmanagement64 2.Glossary67 3.Qualityriskmanagementprocess70 3.1InitiatingaQRM...
For any impurity that cannot be controlled to this limit, a higher limit should bequalified according to the guidance provided in section 3.2.S.3.2 of the generic guide (Annex 4, TRS970).除某些青蒿素衍生物或发酵类API,或含有此类API的FPP外,所有非特定杂质的限度均应符合ICH Q3A/Q3B的鉴别阈值...