摘要
提出药品生产质量管理规范(简称GMP)质量体系有效性评价的模糊综合评价方法,并运用该方法对1个制药公司的GMP质量体系的有效性进行实际测评分析。模糊综合评价方法运用模糊数学理论,从质量方针和目标、产品质量的稳定性、质量改进与创新、资源管理4个方面来综合评价制药GMP质量体系运行的有效性,评价结果具有整体性。
A fuzzy comprehensive evaluation system was proposed and it was used to evaluate the effectiveness of the GMP quality system of a pharmaceutical company.The system was established to evaluate the effectiveness of GMP quality system using a fuzzy mathematics theory based on the policy and goal of quality,stability of the product＇s quality,quality improvement and innovation,and resource management.The evaluation system provided a complete algorithm for the GMP quality system evaluation process.
出处
《广西科学院学报》
2011年第4期311-313,共3页
Journal of Guangxi Academy of Sciences
关键词
评价方法
模糊综合评价
GMP
质量体系
有效性
evaluation method
fuzzy comprehensive evaluation
GMP
quality system
effectiveness
