WHO发布新化学药品TRS 1025

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WHO Expert Committee on Specifications for Pharmaceutical Preparations: fifty-fourth report
WHO Technical Report Series, no. 1025
21 April 2020 | Technical report

总览
世卫组织技术报告丛书提供了各个国际专家组的调查结果，这些专家组向世卫组织提供了有关广泛医学和公共卫生主题的最新科学和技术建议。这类专家小组的成员以个人身分而不是政府或其他机构的代表任职；他们的观点不一定反映世卫组织的决定或既定政策。

http://www.who.int/publications-detail/978-92-4-000182-4

剑魔

非蒸馏注射水的制备

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Annex 1 Procedure for the elaboration, revision and omission of monographs and other texts for The International Pharmacopoeia
Annex 2 International Atomic Energy Agency and World Health Organization guideline on good manufacturing practices for radiopharmaceutical products
Annex 3 Production of water for injection by means other than distillation
Annex 4 Good chromatography practices
Annex 5 Quality management system requirements for national inspectorates
Annex 6 Points to consider for manufacturers and inspectors: environmental aspects of manufacturing for the prevention of antimicrobial resistance
Annex 7 Good storage and distribution practices for medical products
Annex 8 Points to consider for setting the remaining shelf-life of medical products upon delivery
Annex 9 World Health Organization/United Nations Population Fund Prequalification Programme guidance for contraceptive devices: male latex condoms, female condoms and intrauterine devices
Annex 10 World Health Organization/United Nations Population Fund technical specifications for male latex condoms
Annex 11 World Health Organization/United Nations Population Fund specifications for plain lubricants
Annex 12 WHO “Biowaiver List”: proposal to waive in vivo bioequivalence requirements for WHO Model List of Essential Medicines immediate-release, solid oral dosage forms
Annex 13 WHO guideline on the implementation of quality management systems for national regulatory authorities

syhorchid

了解一下

Sam2007

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部分翻译：https://www.ouryao.com/thread-530924-1-1.html

xqliu

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胜利者

顶起

维塔斯Vitas

剑魔 发表于 2020-5-2 13:51
非蒸馏注射水的制备

2018拿来还卖钱啊

小金库

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