摘要
目的:对药品生产中的偏差分析进行初步的探讨。方法:介绍偏差的相关概念,结合GMP的精神和质量保证的要求,阐述偏差分析在药品生产中的重要意义,提出具体的实施方法。结果与结论:在药品的生产中,偏差分析是质量保证体系不可或缺的组成部分。
Objective： To carry out the preliminary discussion on the results from the analysis of deviation occurred in pharmaceutical production. Method： To introduce the relevant concepts of deviation. Combined with the essentials of GMP and the requirements of quality guarantee, the importance of deviation analysis in pharmaceutical production was demonstrated and the concrete execution methods were presented. Results and Conclusion： In pharmaceutical production, deviation analysis is the necessary part in quality assurance system.
出处
《医药工程设计》
2008年第1期37-40,共4页
Pharmaceutical Engineering Design
关键词
偏差
GMP
药品生产
deviation
GMP
pharmaceutical production
