《中国药典》2015年版灭菌法的修订研究

Investigaotion on the revision of sterilization methods in the Chinese Pharmacopoeia 2015

目的:国家药典委员会“2017年度药品医疗器械审评审批制度改革专项课题”子课题之一《中国药典》灭菌法通则修订(课题编号:ZG2017-4-03),研究成果将作为《中国药典》2020年版灭菌法通则修订的参考。方法:在充分调研的基础上,通过查阅国内外相关法规和技术指南,结合我国无菌药品生产实际情况,提出相应的修订建议。结果与结论:无菌药品是药品中要求最为严格、风险最大的一类产品,受到污染的无菌药品一旦流入市场,会造成严重危害,甚至危及患者生命。建议《中国药典》灭菌法通则涵盖适宜灭菌方式的选择,灭菌工艺的开发及验证,以及日常生产控制、变更控制等方面,并体现质量源于设计和风险管理的理念。

Objective:The results of sterilization methods in the Chinese Pharmacopeia of drug standards study sub-subject(No.ZG2017-4-03),as one of the Chinese Pharmacopoeia Commission′s reform of the drug and medical device review and approval system special subjects,will be an important reference for the sterilization methods revision of general chapters of the Chinese Pharmacopoeia 2020.Methods:The revision suggestions are made after reviewing the foreign and domestic regulations and guidances,and considering the domestic actual manufacture situation.Results and Conclusion:There are the strictest requirements for the sterile producs with the highest risk.Once the polluted sterile productions enter into the market,there would be serious hardards and even life-threatening for patients.The Chinese Pharmacopoeia need cover the appropriate sterilization methods for selection,development and validation of sterilization process,routine manufacture control and change control etc.,and presents the idea of quality by design and risk management.