欢迎您注册蒲公英
您需要 登录 才可以下载或查看，没有帐号？立即注册
x
本帖最后由 一沙一叶 于 2017-4-26 14:54 编辑
In case of an initial application for a Certificate of Suitability (CEP), EDQM's assessors attach particular importance to the detailed description of impurities that may occur during the synthesis of the API. Again and again, deficiencies in the application dossiers lead to further requests to the applicants and thus to the procedure to be delayed. In light of this situation, the EDQM has recently published a "Public Document" entitled " TOP TEN DEFICIENCIES - New Applications for Certificates of Suitability for chemical purity (2015-2016)". This document contains a hit list of deficiencies compiled on the basis of a sample of 20 deficiency letters sent between the second half of 2015 and the beginning of 2016. The deficiencies refer to the description of impurities, their analytics and control as well as specifications and their justification. The document precisely informs about which data are expected by the assessors from the applicants. Here is the overview of the deficiencies hit list: TOP 1 (S.3.2)“关于最终物质中含有可能致突变的杂质的风险的讨论缺失或者不足” TOP 1 (S.3.2): "Absence or deficient discussion on the risk of having potential mutagenic impurities in the final substance." TOP 2 (S.2.3):“从起始材料（包括）中转移到最终物质中的有关物质的讨论缺失或者不足” TOP 2 (S.2.3): "Absence or insufficient discussion on fate and carryover of related substances of starting materials (included) to the final substance." TOP 3 (S.2.2, S.2.4)：“从起始材料的引入开始，药用物质的生产工艺的细节不足和/或描述不清（合成，叙述性描述，流程图，回收率和返工程序）。 S.2.2 和S.2.4.部分内容不一致”。 TOP 3 (S.2.2, S.2.4): "Lack of details and/or poor description of the manufacturing process of the substance from the introduction of starting materials (synthesis, narrative description, flow charts, recovery and reprocessing procedures). Incongruences noted between information given in section S.2.2 and section S.2.4." TOP 4 (S.2.3)：“起始物料不可接受，需要再工艺初始的时候重新定义。” TOP 4 (S.2.3): "Non-acceptable starting materials, necessity to redefine them earlier in the process."
TOP 5 (S.2.3)：“现场控制起始物料的质量的标准不充分或合理性不足” TOP 5 (S.2.3): "Non-adequate or poorly justified specifications in place to control the quality of starting materials."
TOP 6 (S.2.3)“从起始物料引入开始，用于生产药用物质的试剂和溶剂（包括回收和再生的）的标准（和分析方法）不充分或缺失” TOP 6 (S.2.3): "Non-adequate or missing specifications (and analytical methods) for reagents and solvents (recovered and recycled included) used to manufacture the substance from the introduction of starting materials."
TOP 7 (S.3.2)“对于试剂和元素杂质转移到最终药用物质讨论不充分或缺失” TOP 7 (S.3.2): "Non-adequate or missing discussion on carryover of reagents and elemental impurities to the final substance."
TOP 8 (S.2.4)“现场控制分离的中间体的质量的标准不充分或合理性不足” TOP 8 (S.2.4): "Non-adequate or poorly justified specifications in place to control the quality of isolated intermediate."
TOP 9 (S.3.2)“从合成的中间体（包括）转移到最终的药用物质杂质的讨论缺失或者不足” TOP 9 (S.3.2): "Absence or insufficient discussion on fate and carryover of impurities from synthetic intermediates (included) to the final substance."
TOP 10 (S.2.3)“起始物料的合成和它们的生产商的信息不充分或者缺失” TOP 10 (S.2.3): "Non-adequate or missing information on the synthesis of starting materials and their manufacturers."
| 
|手机版|蒲公英|ouryao|蒲公英
( 京ICP备14042168号-1 ) 增值电信业务经营许可证编号：京B2-20243455 互联网药品信息服务资格证书编号：(京)-非经营性-2024-0033
发表于 2017-4-25 21:47:07
置顶卡
变色卡
还是我理解错了呢
楼主