《更新》【重要】 WHO/治験薬のGMPおよび研究開発施設に関してのGood Practicesガイドラインの最終版が発出
※初出掲載(2023.01.31)
※追記更新(2023.02.01)
2021年7/29付(追記更新あり)GMP Platformトピック「WHO/治験薬のGMPおよび研究開
関係者および興味のある方は、下記URLsのウェブサイト、
l Reportウェブサイト「TRS 1044 - 56th report of the WHO Expert Committee on Specifications for Pharmaceutical Preparations」
https://apps.who.int/iris/rest/bitstreams/1486295/retrieve
l 2022年12/22付「TRS 1044 - 56th report of the WHO Expert Committee on Specifications for Pharmaceutical Preparations」
https://www.who.int/
l 治験薬のGMPウェブサイト「TRS 1044 - Annex 7: WHO good manufacturing practices for investigational products」
https://www.who.int/
l 2022年8/31付「Annex 7 WHO good manufacturing practices for investigational product」~TRS 1044のAnnex 7です。
https://cdn.who.int/media/
l R&A施設のウェブサイト「TRS 1044 - Annex 6: WHO good practices for research and development facilities of pharmaceutical products」
https://www.who.int/
l 2022年9/30付「Annex 6 WHO good practices for research and development facilities of pharmaceutical products」~TRS 1044のAnnex 6です。
https://cdn.who.int/media/
【2/1付追記更新】
上記のWHO Expert Committeeによる「「TRS 1044 - 56th report of the WHO Expert Committee on Specifications for Pharmaceutical Preparations」」は、複数のAnnexes(202
今回は、以下のAnnexesが取り上げられていますが、
Annex 1:Guidelines and guidance texts adopted by the Expert Committee on Specifications for Pharmaceutical Preparations
Annex 2:WHO good manufacturing practices for sterile pharmaceutical products~PIC/S GMP Annex 1(EU-GMP Annex 1)との協業なので内容はほぼ同じです。
Annex 3:IAEA/WHO guideline on good manufacturing practices for investigational radiopharmaceutical products
Annex 4:WHO guidelines on technology transfer in pharmaceutical manufacturing
Annex 5:WHO good manufacturing practices for medicinal gases
Annex 6:WHO good practices for research and development facilities of pharmaceutical products
Annex 7:WHO good manufacturing practices for investigational products
Annex 8:Points to consider for setting the remaining shelf-life of medical products upon delivery
Annex 9:WHO/UNFPA guidance on natural rubber latex male condom stability studies
Annex 10:WHO/UNFPA technical specification for TCu380A intrauterine device
Annex 11:WHO Biowaiver List: proposal to waive in vivo bioequivalence requirements for WHO Model List of Essential Medicines immediate-release, solid oral dosage forms
最近のWHOガイドライン等は、
この機会に読んでみては、いかがでしょうか。
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