摘要
目的浅析国外客户对原料药的质量审计。方法介绍了质量审计的目的和特点,并针对客户审计的重点,按审计过程进行详细论述和分析。结果与结论在准备和接受国外客户质量审计的活动中,完善了自身的质量管理体系,提高了企业的产品质量水平和国际市场竞争力。
Objective To analyze the quality audit of active pharmaceutical ingredients （APIs） by foreign clients. Methods The article introduces the objectives and characteristics of quality audit by foreign clients, and elaborates the process, focusing on its key points. Results and Conclusion In the process of preparing for and accepting quality audit by foreign clients, the quality management system of the company has been perfected and its product quality as well as international market competitiveness have been improved.
出处
《中国药事》
CAS
2012年第5期534-536,共3页
Chinese Pharmaceutical Affairs
关键词
原料药
GMP
质量审计
国外客户
active pharmaceutical ingredients （APIs）
GMP
quality audit
foreign clients
