权威医学用药书籍速查系统

3. GLOSSARY

Continuous ? Process ? Verification : An alternative approach to process validation in which manufacturing process performance is continuously monitored and evaluated .Design ? Space : The multidimensional combination and interaction of input variables ( e . g . , material attributes ) and process parameters that have been demonstrated to provide assurance of quality .This term includes such attributes as the identity , strength , and purity ( from ICH Q6A Specifications Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products : Chemical Substances ) .

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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 I: PHARMACEUTICAL DEVELOPMENT
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:376-377
版本:1
出版时间:2011-01-01
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