Toptendeficienciesfoundafterfirstassessmentof..doc

Top ten deficiencies found after first assessment of new applications in 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. 这个文件是化学纯度的COS新申请初次评审存在主要问题的摘要。它是基于2011年的第一个月份给申请人的90份缺陷信的内容。 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). 从获得数据来看，每个申请的平均缺陷数是7，实际数量范围是0到14.在这期间，有2个CEP是在第一次评审后获得的（处理90份文件） 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. EDQM要求补充的 10个频率最高的问题和建议列在下面。网站中包括它们的建议，EDQM指南中描述的要求“化学纯度文件的内容” PA/PH/CEP (04) 1 (现行版本) –申请人提高他们文件的质量以促进和加快他们CEP的申请。 TOP 1 (3.2.S.2.3): Absence of discussion on the carry-over of impurities/by-products from key materials in the process: 前1(3.2.S.2.3)：没有讨论工艺中关键物料的杂质/副产物的残留： The impurities (related substances, solvents, catalysts) of the key materials of the process (starting materials, intermediates) should be described; their carry-over as well as the formation of by-products in the final substance should be discussed. In some cases, a scientific discussion demonstrating/justifying the absence of impurities may replace analytical testing and batch results. The European guidelines on residual solvents, genotoxic impurities