《药品生产质量管理规范》(good manufacturing practice,简称:GMP)是药品生产企业必须遵守的药品生产和质量管理的基本准则,GMP文件是药品质量保证体系的基本组成部分。一个运行良好的制药企业,不仅靠先进的制药厂房设施和设备等硬件的支撑,也要靠管理软件来运行,管理软件的基 “Good manufacturing practice” (GMP) is the basic guideline for pharmaceutical manufacturers to comply with drug production and quality management. GMP documents are an essential part of the drug quality assurance system. A well-run pharmaceutical company, not only by the advanced pharmaceutical plant facilities and equipment such as hardware support, but also by management software to run the management software base