中药黑膏药制剂生产中的质量风险管理

Quality Risk Management in Production of Black Plaster

通过对危害分析与关键控制点(HACCP)的概念、优点和应用原则的简单介绍,将其应用于中药黑膏药制剂的生产过程,以对黑膏药进行质量风险管理。对黑膏药的生产过程进行危害分析得到11个关键控制点,通过对关键控制点的控制、关键限值的建立、纠正措施的制定等对黑膏药实施质量风险管理。

This paper introduces the concept, advantages and applied principles of hazard analysis and critical control point （HACCP）. HACCP was applied in production of black plaster to carry out quality risk management of black plaster. 11 critical control points were obtained by hazard analysis of the production process of black plaster. Some measures such as control of critical control point, confirmation of key limit value, implementation of the preventive measures were taken to carry out quality risk management of black plaster.