洛施德GMP咨询 - 新CEP申请的十大常见缺陷.pdf

SoltorisManagement Consultants, Inc. 洛施德企业管理咨询（上海）有限公司 TOP TEN DEFICIENCIES of New Applications for Certificates of Suitability 新CEP 申请的十大常见缺陷 From the data obtained, the average number of questions for each application is 10 with the actual number of questions ranging from 2 to 20. During this period of reference, no CEP was granted after the first evaluation. 从得到的数据看，每个申请平均问题数为10 个，实际问题数从2 到20 不等，此间没有CEP 是在第一次评审 后即签发的。 The Top 10 questions are listed below with additional 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. 十大问题在下面一一列出，并给出了符合EDQM 要求的建议。有了这些建议-与EDQM 指南“化学纯 度档案内容” （现行版本，在官网可得）中描述的要求一起— 申请人可以提高文件质量，有助于并更快地获得 CEP 。 TOP 1 (3.2.S.2.2) / (3.2.S.2.3): Redefinition of starting material: 第1 大缺陷(3.2.S.2.2) / (3.2.S.2.3) ：起始原料的重新界定 More and more frequently, applicants propose a one-step synthesis, starting from a complex material in the application. This is generally not acceptable and the complex material is considered as a late, often purchased, intermediate in the synthesis. 越来越多的申请人在申请中提请从结构复杂的原料开始一步合成，这种申请通常不被接受，复杂结构的（通 常采购来的）原料会被认为是合成路线中较后的中间体。 Applicants are reminded that the approved starting material is the starting point for GMP and variations, and must be representative of the overall synthetic process and not just a late intermediate resulting in a shortened synthesis. The proposed starting material must be justified. This proposal and justification will be assessed and can lead to a request for redefinition of the starting material. 需要提醒申请人的是批准的起始原料是GMP 的起始点和差异点，必须能代表整个合成工艺而不是最后中间体 从而缩短合成路线。这个提议和论证会被评价，可能导致要求对起始原料重新界定。 As a conse