中国药房2012，Vol.23Issue(41)：3863-3865,3.DOI:10.6039/j.issn.1001-0408.2012.41.09
我国药品认证检查机构建立统一的质量管理体系的必要性分析
Analysis of the Necessity of Establishing Uniform Quality Management Systems in Pharmaceutical Certification and Examination Institution in China
洪钢1
作者信息
- 1. 江苏省食品药品监督管理局认证审评中心,南京210002
- 折叠
摘要
Abstract
OBJECTIVE: To discuss the necessity of establishing uniform quality management systems in pharmaceutical certification and examination institution in China. METHODS: The problems of current quality management were analyzed in pharmaceutical certification and examination institution. The necessity of quality management systems in pharmaceutical certification and examination institution were introduced from the risk of pharmaceutical certification, the construction of pharmaceutical certification and examination institution, requirements of regulation and international mutual recognition. RESULTS & CONCLUSIONS: The problems of pharmaceutical certification and examination institution are bad quality conception and risk consciousness, the weakness of quality management and incompatibility of quality management with pharmacoeconomic development. Uniform quality management system is an effective tool in reducing risk of pharmaceutical certification, improving the level of pharmaceutical certification and management, increasing the ability of regulation complying and improving international mutual recognition.关键词
药品认证检查机构/质量管理体系/统一/建立/必要性Key words
Pharmaceutical certification and examination institution/ Quality management systems/ Uniform/ Establishment/ Necessity分类
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洪钢..我国药品认证检查机构建立统一的质量管理体系的必要性分析[J].中国药房,2012,23(41):3863-3865,3.
