The electronic common technical document - Transition to a new paradigm in regulatory submissions

被引：0
|
作者：
Cook, J
机构：
[1] CDC Solut Ltd, Chippenham SN15 1BN, England
[2] Univ Bath, Bath BA2 7AY, Avon, England
来源：
BIOPHARM INTERNATIONAL-THE APPLIED TECHNOLOGIES OF BIOPHARMACEUTICAL DEVELOPMENT | 2003年
关键词：
D O I：
暂无
中图分类号：
Q81 [生物工程学（生物技术）]; Q93 [微生物学];
学科分类号：
071005 ; 0836 ; 090102 ; 100705 ;
摘要：
While biopharmaceutical companies work to bring their equipment and processes into compliance With 21 CFR Part 11, they should also keep abreast of ICH regulations on electronic submissions regulations that will soon be FDA requirements so that they don't have to redo their new operating and authoring procedures.
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页码：24 / 27
页数：4
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