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scu_zhulei

木虫 (正式写手)

[求助] 如何翻译呢 谢谢 已有1人参与

Change in the manufacturer of a starting material / reagent
/ intermediate used in the manufacturing process of the active substance
or change in the manufacturer (including where relevant quality control
testing sites) of the active substance, where no Ph. Eur. certificate of
suitability is part of the approved dossier: Introduction of a new
manufacturer of the active substance that is not supported by an ASMF and
requires significant update to the relevant active substance section of the
dossier
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woaichenog

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【答案】应助回帖

★ ★ ★ ★ ★ ★ ★ ★ ★ ★
感谢参与,应助指数 +1
scu_zhulei: 金币+10, ★★★★★最佳答案, 感谢 参考使用 2015-04-22 17:27:27
用于活性物质生产的起始物料/试剂/中间体,其生产商的变更或者活性物质生产商(包括有关质量检测控制的场地)的变更,若无COS,应作为批准档案的一部分;采用无ASMF支持的新的活性物质生产商,需要对档案中有关活性物质部分做重大更新。
仅供参考!
2楼2015-04-22 17:00:18
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