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药品生产质量管理规范(GMP)是药品生产管理和质量控制的基本要求,GMP认证是国家食品药品监督管理局对制药企业的监督、检查措施。《药品生产质量管理规范(2010年修订)》发布以来,在新版GMP认证中,经常会碰到企业文件执行、人员配置培训、环境条件等问题。本文通过对新版GMP的理解,针对工作中遇到的问题,提出切实可行的对策,为制药行业进行更为科学、系统、有效的药品生产和质量管理提供分析思路。
The GMP is the basic requirement of pharmaceutical production management and quality control. GMP certification is the supervision and inspection of the pharmaceutical enterprises by the State Food and Drug Administration. Since the release of the “Code of Practice for the Quality Control of Pharmaceutical Production (Revised in 2010)”, in the new version of GMP certification, enterprises often encounter such problems as the execution of enterprise documents, personnel training, and environmental conditions. This article through the understanding of the new version of GMP, in view of the problems encountered in the work, put forward feasible countermeasures for the pharmaceutical industry to provide more scientific, systematic and effective drug production and quality management provide analysis ideas.