药品GMP的精髓在于生产车间的合理设计与布局以及在药品生产过程中,实行全程规范化管理,防止药品的污染、交叉污染和混淆,确保药品安全有效和质量均一。笔者根据多年来从事GMP管理和生产的经验和教训,结合《药品生产质量管理规范》和《洁净厂房设计规范》,就固体制剂GMP车间的合理设计与布局提出几点看法,与广大制药工作者探讨。 The essence of pharmaceutical GMP lies in the rational design and layout of the production workshop as well as the standardized management throughout the entire process of drug production to prevent the contamination, cross contamination and confusion of medicines so as to ensure the safety, effectiveness and quality of the medicines. Based on the experience and lessons learned from GMP management and production over the years, the author puts forward some suggestions on the rational design and layout of the GMP workshop for solid preparations in combination with the “Code of Practice for the Quality Control of Pharmaceutical Production” and the “Code for Design of Clean Factories” Discussion.