EDQM更新汇总

Revised: “Validation of Computerised Systems” Guideline

修订“计算机化系统验证”指南

2018.04.09

The revised guidelines are the following：

修订了下述指南：

Validation of Computerised Systems - Core Document

计算机化系统验证——核心文件

Validation of Computerised Systems Annex 1: Validation of Excel Spreadsheets

计算机化系统验证 附录1：对Excel表格的验证

Validation of Computerised Systems Annex 2: Validation of Complex Computerised Systems

计算机化系统验证 附录2：复杂计算机化系统的验证

All three parts of the guideline will come into force on 1 August 2018.

指南的这三个（所有）部分，都将于2018年8月1日生效。

https://www.edqm.eu/en/news/revised-validation-computerised-systems-guideline

The Ph. Eur. revises its general chapter on Infrared Absorption Spectrophotometry

欧洲药典修订红外吸收分光光度法的总论

2018.04.06

The chapter on Infrared Absorption Spectrophotometry (2.2.24) is one of the original cornerstones of pharmacopoeial testing, referenced in many general texts and more than 1200 individual monographs.

关于红外吸收分光光度法的章节（2.2.24）是药典检测的原始基础之一，被很多总论和1200多个单独的专论引用。

It will be effective on 1 April 2019 and will be published in Supplement 9.7 of the Ph. Eur.

它将于2019年4月1日生效，且将在欧洲药典的增刊9.7中出版。

目前，该网站仅给出了修订的大纲。

https://www.edqm.eu/en/news/ph-eur-revises-its-general-chapter-infrared-absorption-spectrophotometry

European Pharmacopoeia Reference Standards recently released

欧洲药典近期放行的对照品

2018.04.03

Y0001954 N-acyl-phosphatidylethanolamine from Soya bean

Y0001981 Mometasone furoate monohydrate

Y0001961 Tigecycline

Y0001988 Succinic acid

https://www.edqm.eu/en/news/european-pharmacopoeia-reference-standards-recently-released