浅谈固体制剂生产偏差的管理

摘要

OBJECTIVE To investigate the management of deviations in the production of solid prepara-tions.METHODS The related concept of deviation and deviation management were introduced ,combined with the specific requirements of GMP standard ,the deviation ,deviation handling implementation program and valicl methods in solid preparation production were described .RESULTS and CONCLUSION In the solid preparation produc-tion,the whole process of deviation management throughout the solid preparation production which , is an important component in the quality assurance system .%目的：对固体制剂生产中的偏差管理进行探讨。方法介绍偏差及偏差管理的相关概念，结合 GMP规范的具体要求，阐述了固体制剂生产的偏差范围、偏差处理程序及具体的实施方法。结果与结论在固体制剂生产中，偏差管理贯穿于固体制剂生产的全过程，是质量保证体系的重要组成部分。