眼用制剂生产质量管理风险分析及控制

Risk Analysis and Control Strategies of Production and Quality Management of Ophthalmic Preparations

随着中国药典2010年版将眼用制剂列入无菌制剂,眼用制剂的生产质量管理被提出了更高的要求。本文对目前眼用制剂生产现状进行分析,探讨眼用制剂生产与质量控制的关键风险点,并提出了一些风险控制策略,为企业提供参考。

Since ophthalmic preparations were defined as sterile preparation by Ch.P 2010, the requirement of production and qulity management of ophthalmic preparations is raised. The production status and the main risk points of the production and quality management of ophthalmic preparations are reviewed and discussed in this article as well as control strategies, aiming to provide some references to manufacturers.