2012016年化学纯度cep新申报资料十大缺陷.pdf

PA/PH/CEP (16) 58 TOP TEN DEFICIENCIES New Applications for Certificates of Suitability for chemical purity (2015-2016) Certification of Substances Department CSA/Cb PUBLIC DOCUMENT (LEVEL 1) PA/PH/CEP (16) 58 Strasbourg, December 2016 Certification of suitability to the Monographs of the European Pharmacopoeia TOP TEN DEFICIENCIES New Applications for Certificates of Suitability for chemical purity (2015-2016) 2015-2016年度化学纯度CEP新申报资料十大缺陷 Address: 7 Allée Kastner, CS 30026 F -67081 Strasbourg (France) Tel: +33 (0) 3 88 41 30 30 – Fax: +33 (0) 3 88 41 27 71 - e-mail: cep@edqm.eu Internet: http://www.edqm.eu PA/PH/CEP (16) 58 2015-2016 年度化学纯度CEP 新申报资料十大缺陷 翻译 Julia 页 1/7 PA/PH/CEP (16) 58 TOP TEN DEFICIENCIES New Applications for Certificates of Suitability for chemical purity (2015-2016) This document is a summary of the ten most frequent questions raised after t he initial evaluation of new applications for Certificates of suitability (CEP) for chemical purity. It is based on the content of a sample of 20 deficiency letters sent selected randomly during the second half of 2015 and beginning of 2016. 本文是对化学纯度CEP新申报资料初次审评中发现的最常见十大问题的总结。该总结是基于2015年下半年 和2016年初期间随机抽取的20封缺陷信内容。 The top ten most frequent questions are listed below together with expectations and recommendations on how to address the specific deficiencies, with reference to applicable guidelines. 以下列出了十大最常见问题，以及EDQM期望和建议如何解决这些缺陷和相关的适用指南。 This document is intended to help applicants to improve the quality of their dossiers, in order to facilitate and speed up t