摘要
介绍冻干粉针剂生产过程中存在的质量风险,通过控制生产过程中的管理要点,加强过程控制,将质量问题消除在生产过程中,从而提高非最终灭菌制剂的无菌保证水平和降低其他质量风险.
Quality risks in the production process of freeze-dried powder injection were introduced,Through controlling the management in the production process and strengthening the process control,quality problems would be eliminated in production process,so as to improve the level of sterilization of final preparations and to lower other quality risks.
出处
《齐鲁药事》
2011年第9期548-549,共2页
qilu pharmaceutical affairs
关键词
冻干粉针剂
质量风险
管理细节
Freeze-dried powder injection
Quality risk
Management details
