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药品生产质量管理规范是由美国最先发布的一种针对药厂生产过程的全面质量控制规范性文件,本文从它的必要性和在我国实施的情况和存在的问题,以及GMP后时代的问题和对策做了简要的叙述。
The quality control of pharmaceutical production is the first comprehensive quality control normative document issued by the United States aimed at the production process of pharmaceutical factory. This paper analyzes the necessity and necessity of implementing quality control in our country, the existing problems and the problems in the post-GMP era And countermeasures made a brief description.