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5. The presentation will cover the latest regulatory approaches on process validation as well as the pr

The presentation will cover the latest regulatory approaches on process validation as well as the pr

来源 :2015年中国药物制剂大会、中国药学会药剂专业委员会2015年学术年会暨国际控释协会中国分会2015年学术年会 | 被引量 : 0次 | 上传用户：zhmj1985

【摘 要】

：

With the implementation ofICH Q8, Q9, Q10 and Q11 guidelines and the USFDA Process Validation guidance and issue of EMAs Process Validation guideline and Annex 15, the need to understand the science-a

【作 者】

：

雷继峰 

【出 处】

：

2015年中国药物制剂大会、中国药学会药剂专业委员会2015年学术年会暨国际控释协会中国分会2015年学术年会

【发表日期】

：

2015年9期

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With the implementation ofICH Q8, Q9, Q10 and Q11 guidelines and the USFDA Process Validation guidance and issue of EMAs Process Validation guideline and Annex 15, the need to understand the science-and risk-based approach to management of the product lifecycle will be addressed.

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