摘要
药品是一种特殊商品,药品生产受政策、法规、市场等多种外部因素影响,也受人员、环境、管理等各种内部条件制约。为了加强药品生产管理和质量控制,最大限度地降低药品生产过程中污染、交叉污染,有效地防止混淆和差错,确保持续稳定地生产出符合要求的产品,2010版GMP增加了"质量风险管理"概念。从风险管理角度入手,分析制药企业在新形势、新要求下如何对生产过程中存在的质量风险进行有效管理,是提高产品质量的关键。
Drug is a special kind of commodity and its production could be affected by both external factors （such as policy, regulation and market） and internal factors （including personnel, environment and management）. Good Manufacturing Practice 2010 edition has added the concept of ＂Quality Risk Management,＂ in order to enhance the manufacturing management and quality control, minimize the contamination and cross-contamination, avoid mix-ups and mistakes effectively, and to make sure the products meet the requirement continuously and stably during the drug manufacturing process. In this article, we have discussed how to make an effective management of the quality risk during the manufacturing process in the new situation and new requirement, in order to improve the product quality.
出处
《中国医药科学》
2013年第1期161-162,共2页
China Medicine And Pharmacy
关键词
制药企业
质量风险
管理
Pharmaceutical enterprise
Quality risk management
Management
