药品生产的偏差分析

Deviation analysis during drug manufacturing process

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的原则和质量保证的要求,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 discuss primary deviation analysis during drug manufacturing processes.Methods: The related concept of deviation was introduced,the significance of deviation analysis in drug production was elucidated and specific practical methods according to the principles of GMP and the requirements of quality assurance were provid- ed.Results and Conclusion:Deviation analysis is necessary for quality assurance system in drug production.