权威医学用药书籍速查系统

3 . 2 Pharmaceutical Quality System Elements

The elements described below might be , required in part under regional GMP regulations .However , the Q10 model ’ s intent is to enhance these elements in order to promote the lifecycle approach to product quality .The change management system should include the following , as appropriate for the stage of the lifecycle : Quality risk management should be utilised to evaluate proposed changes.Provision, training and/or realignment of resources .

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——《2011药品注册的国际技术要求.质量部分》
书名:《2011药品注册的国际技术要求.质量部分》
栏目:2011药品注册的国际技术要求.质量部分 > PHARMACEUTICAL QUALITY SYSTEM Q 1 0 > PHARMACEUTICAL QUALITY SYSTEM > 3 . C O N T I N U A L I M P R O V E M E N T O F P R O C E S S PERFORMANCE AND PRODUCT QUALITY
作者:美国ICH指导委员会 周海钧
参编:王执,王知坚,匡荣,李洋,张洁
页码:418-425
版本:1
出版时间:2011-01-01
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