制药过程有效化的理论和方法

The Validation Theory and Methodology of Pharmaceutical Process

制药过程有效化是７０年代后逐步发展起来的研究领域，它将有效化理论和手段应用于药品生产。本文概述了制药过程有效化概念、简史、意义。

Pharmaceutical process validation applies the theory and method of process validation to pharmaceutical manufacturing processes.It is a new research field which has been developing progressively since 1970's.The concept,briefhistory,significance,methods and general steps of pharmaceutical process validation were reviewed.