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医药行业是我国重要的工业产业,国家多年来强制推行GMP,与世界医药管理接轨,实施GMP,医药生产企业需要建立一套完整科学的文件系统。本文就学习贯彻国家食品药品监督管理局修订的GMP,结合多年从事药品生产企业管理经验,探讨了建立符合GMP原则规定、符合企业生产实际的文件系统。
The pharmaceutical industry is an important industrial industry in our country. Since the country has forced the implementation of GMP for many years, it is in line with the world pharmaceutical management and the implementation of GMP. The pharmaceutical manufacturing enterprises need to establish a complete and scientific file system. This article will study and implement the GMP revised by the State Food and Drug Administration, combined with many years of experience in the management of pharmaceutical manufacturing enterprises, discussed the establishment of a document system that complies with the GMP principles and in line with the actual production of enterprises.