EMA-制药用水指南（中英文版）.pdf

EMA--Guideline on the quality of water for pharmaceutical use EMA/CHMP/CVMP/QWP/496873/2018 20 July 2020 EMA/CHMP/CVMP/QWP/496873/2018 Committee for Medicinal Products for Human Use (CHMP) Committee for Medicinal Products for Veterinary Use (CVMP) Guideline on the quality of water for pharmaceutical use 制药用水质量指南 Draft agreed by Quality Working Party 7 June 2018 质量工作组通过草案 2018-07-07 Adopted by CHMP for release for consultation 28 June 2018 CHMP 采纳，发布征求意见 2018-06-28 Adopted by CVMP for release for consultation 19 July 2018 CVMP 采纳，发布征求意见 2018-07-19 Start of public consultation 15 November 2018 开始征求公众意见 2018-11-15 End of consultation (deadline for comments) 15 May 2019 征求意见截止 2019-05-15 Agreed by GMDP IWG 5 March 2020 GMDP IWG 通过 2020-03-05 Agreed by BWP 18 March 2020 BWP 通过 2020-03-18 Agreed by QWP 6 May 2020 QWP 通过