药品良好生产规范：从制造商到消费者的全面质量管理计划，第五版

Sidney H. Willig | 2000 | ISBN: 0824704258 | English | 732 pages | PDF | 10 MB

Examines US law and governmental policy affecting domestic and multinational pharmaceutical manufacturing. This book recommends pragmatic ways to interpret and comply with FDA CGMP regulation and related criteria, they focus on geographical redistribution of manufacturing facilities, adaptation to disparate human resources, and others.

本书探讨了影响国内和跨国制药制造的美国法律和政府政策。这本书推荐了务实的方法来解释并遵守FDA CGMP法规及相关标准，重点在于制造业设施的地缘性重新分配、适应不同人力资源等方面。

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