化学药品注射剂的灭菌或无菌工艺现行要求及考虑  

Considerations and current requirements for sterility assurance of parenteral drug

作　　者：张帆 孙沣 刘福利 HANG Fan;SUN Feng;LIU Fuli(Center for Drug Evaluation,National Medical Products Administration,Beijing 100076,China)

机构地区：[1]国家药品监督管理局药品审评中心,北京100076

出　　处：《药物评价研究》2023年第12期2551-2557,共7页Drug Evaluation Research

摘　　要：化学药品注射剂是临床上应用较广的一类无菌药品,鉴于其较高的安全性风险,确保注射剂的无菌性尤为关键。结合中国、美国和欧盟对注射剂的无菌保障监管及药品生产质量管理规范(GMP)指南的现行要求,进一步探讨化学药品注射剂的灭菌或无菌工艺控制。目前,我国化学药品注射剂的灭菌或无菌工艺选择要求与欧美国家基本一致,美国和欧盟对于湿热灭菌注射药品已实施参数放行。通过阐述注射剂灭菌或无菌工艺的评估及研究,为制药企业化学药品注射剂无菌保障控制策略及无菌风险管控的不断完善提供参考,以更好地提高注射剂的无菌保障。Parenteral drug was a kind of sterile products and widely used in clinical.Based on highly safety risk,it was particularly important to ensure the sterility assurance.To discuss the sterilizing or aseptic process control requirements of parenteral drug,compared China,the United States and the European Union.The requirements with those countries were similar,the United States and the European Union implemented parametric release of parenteral drug terminally sterilized by moist heat.With the evaluation and research on sterilizing or aseptic process,this paper provided reference for pharmaceutical to improve the strategy for parenteral drug,and strengthen the sterility of products.

关 键 词：无菌药品 注射剂 药品生产质量管理规范(GMP) 湿热灭菌 无菌工艺 

分 类 号：R951[医药卫生—药学]