摘要
目的提高制剂的安全性,确保其质量有效、可控。方法近年来,国家逐渐加强了医院制剂的监督管理力度。该文以外用制剂为例,以编写依据、地位和关键环节等阐述质量管理体系的建立。结果与结论质量管理体系的建立是医疗机构制剂生产并通过相关认证的基础性要求和考核依据。
Objective To improve the safety of the preparation and ensure its quality is effective and controllable. Methods In recent years,China has gradually strengthened the supervision and management of hospital preparations. An external preparation was taken as an example to discuss the establishment of quality management system in terms of the bases, status and key factors of compiling. Results and Conclusion The establishment of quality management system is the basic requirement and examination basis for the production and certification of preparation in medical institutions.
出处
《中国药业》
CAS
2017年第21期91-93,共3页
China Pharmaceuticals
基金
上海市临床药学重点专科建设项目[2016-40044-002]
