论文部分内容阅读
目的:介绍在药品生产过程中如何有效的防范污染与交叉污染。方法:查阅近几年的文献以及日常工作中的一些经验积累。结果:主要污染为空气、表面、设备、物料和人员以及生产过程中产生或带入;传播方式主要有直接污染和交叉污染。结论:防范污染应从药品生产的环境、人员、物料、空气通道的洁净控制等方面采取措施以及对生产过程进行严格的监控,严格按《药品生产质量管理规范》的要求组织生产。
Objective: To introduce how to effectively prevent pollution and cross contamination in the process of drug production. Methods: Review the literature in recent years and some accumulated experience in daily work. Results: The main pollution was air, surface, equipment, materials and personnel as well as produced or brought into the production process. The main modes of transmission were direct pollution and cross-contamination. Conclusion: Prevention of pollution should take measures such as the environment, personnel, materials and clean control of the air channel of the drug production as well as the strict monitoring of the production process. The production should be organized strictly according to the requirements of the “Good Manufacturing Practices for Pharmaceutical Production”.