权威医学用药书籍速查系统

4. GLOSSARY

Control ? Strategy : A planned set of controls , derived from current produc and process understanding that ensures process performance and product quality .Real ? Time ? Release ? Testing : The ability to evaluate and ensure the quality of in-process and/or final product based on process data , which typically include a valid combination of measured material attributes and process controls .

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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 DEVELOPMENT Q8(R2) > PART II: PHARMACEUTICAL DEVELOPMENT-ANNEX
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:391-393
版本:1
出版时间:2011-01-01
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