灭菌注射用水分装及灭菌生产工艺验证

摘要

目的：验证所采用的灭菌注射用水分装、灭菌生产工艺符合2010年版《药品生产质量管理规范》附录1的规定,同时满足产品安全性、生产可靠性的要求。方法：以安瓿分装0.5ml/支的灭菌注射用水为研究对象,对影响灭菌注射用水质量的分装、灭菌生产工艺过程进行确认,并进行历史数据的统计分析。结论：通过验证,所有结果符合方案所述的要求,使产品最终达到成品检定标准。%Objective： To determine whether the adopted filling and sterilization process follow the rules specified in Attachment 1, Chinese GMP（2010 Edition） and meet the requirements of product safety and production reliability. Methods：The ampoule that filled with 0.5ml of sterilized WFI was employed to serve as the subjects to confirm the filling and sterilization process that affect the quality of sterilized WFI. Meanwhile, the historical data were statistically analyzed. Results：All results met the requirements in Attachment through validation. Conclusion：All the products reach the testing standards.