Injections have been considered highly risky because they are designed to be injected directly into the blood system. Based on the concept of quality by design(QbD),the sources of quality risks in injections were analyzed; quality target product profile(QTPP)and thecritical quality attributes(CQA)of injections were discussed. Besides,risks of injection formulation and process variables were analyzed,and critical process parameters and control strategies were explored on the foundation of critical material a...
【更新日期】
2014-06-24
【分类号】
R914
【正文快照】
质量可控、安全有效是药物现代评价体系的基本要素。在质量可控方面,近几十年,药品质量管理模式得到了很大程度的提高。由真伪辨别和纯度控制,逐渐发展到“检验决定质量”(quality by testing,QbT),20世纪70年代发展到“质量源于生产”(quality by production,QbP),引入了六大?
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