中国药房2012，Vol.23Issue(37)：3460-3463,4.DOI:10.6039/j.issn.1001-0408.2012.37.02
《药品生产质量管理规范》管理中偏差分类的方法研究
Study on Approaches to Classification of Deviations in GMP Management
梁毅 1陈磊1
作者信息
- 1. 中国药科大学国际医药商学院,南京211198
- 折叠
摘要
Abstract
OBJECTIVE: To provide the approaches to classification of deviations in GMP management. METHODS: According to the periodical documents and training contents from foreign pharmaceutical companies, the approaches to classification of deviations in GMP management were summarized. RESULTS: Three appropriate approaches were summarized: for complicated procedures, the deviations were classified according to risk levels with risk evaluation tools; for simple procedures, according to the deviation situation, namely the impact on product quality and the identification of deviation, the types of deviation were analyzed and identified; during the procedure design period, FMEA was adopted to classify potential deviation. CONCLUSIONS: Classification of deviations is the critical procedure during the deviation management. It is important for manufacturers to establish detailed and scientific procedure according to different technology regulations at different stages and choose suitable methods.关键词
药品生产质量管理规范/偏差/分类/方法Key words
GMP/ Deviation/ Classification/ Methods分类
管理科学引用本文复制引用
梁毅,陈磊..《药品生产质量管理规范》管理中偏差分类的方法研究[J].中国药房,2012,23(37):3460-3463,4.
