TOP TEN DEFICIENCIES2011年度中英解读.pdfVIP

Zhulikou431作品，丁香园论坛首发 Certification of Substances Division PPR/CB PUBLIC DOCUMENT English only/Anglais seulement PA/PH/CEP (12) 15 Strasbourg, June 2012 Certification of suitability to Monographs of the European Pharmacopoeia TOP TEN DEFICIENCIES New Applications for Certificates of Suitability (2011) CEP证书首次申请十大缺陷 2011年度 【译者注释：根据文章内容，应该是 11条缺陷，而且内部目录多次错误，已经纠正。】 Address: 7 allée Kastner CS 30026 - F 67081 Strasbourg Telephone: 33 (0) 3 88 41 30 30 - E-mail:cep@edqm.eu - Fax: 33 (0) 3 88 41 27 71 Internet : http://www.edqm.eu Zhulikou431作品，丁香园论坛首发 Top ten deficiencies found after first assessment of new applications in 2011 CEP证书首次申请评估发现的十大缺陷问题（2011） This document is a summary of the main questions resulting from the first assessment of new applications for Certificates of Suitability (CEP) for chemical purity. It is based on the content of a sample of 90 deficiency letters sent to applicants during the first months of 2011. 本文是化学类别CEP证书首次申请首次评估中发现问题的汇总。本文基于2011年初 发给申请者的90封缺陷函样本中的内容汇总而成。 From the data obtained, the average number of questions for each application is 7, with the actual number of questions ranging from 0 to 14. During the period of reference, 2 CEPs were granted after the first evaluation (out of 90 dossiers treated). 根据获得的数据，每个申请问题的平均数是7，而问题的实际数目是0-14之间。在审 核期间，首次评估就被授予CEP证书的申请数目是2（不在90份需要处理的申请文件 之中）。 The Top 10 most frequent questions are listed below with recommendations regarding EDQM requirements added. By including these recommendations - together with the requirements described in the EDQM Guideline “Content of the dossier for chemical purity” PA/PH/CEP (04) 1 (current version) which is available on our website - applicants can improve the quality of their dossiers with a view to facilitating and speeding up the granting of their CEP. 下面列举了十大缺陷项目，包括EDQM要求的建议。通过附加这些建议，结合EDQM 指南 Content of the dossier for chemical purity PA/PH/CEP (04) 1 (现行版)中的要 求，这个指南可以在EDQM网站上找到，申请者可以提高他们申