浅析化学药品注射剂一致性评价包材相容性研究的法规要求

Analysis of the Technical Guidelines for the Compatibility of Chemical Injections and packaging materials

化学药品注射剂一致性评价涉及的包材相容性指导原则主要有《化学药品注射剂与塑料包装材料相容性研究技术指导原则(试行)》《化学药品注射剂与药用玻璃包装容器相容性研究技术指导原则(试行)》和《化学药品与弹性体密封件相容性研究技术指导原则(试行)》,本文针对上述指导原则,从药品申请人的角度对各指导原则进行解析,以期给药品研发人员一些方向的指引和实操的指南。

The packaging material compatibility guidelines involved in the consistency evaluation of chemical injections mainly include<Technical Guidelines for the Compatibility of Chemical Injections and Plastic Packaging Materials(Trial)>,<Technical Guidelines for the Compatibility of Chemical Injections and Pharmaceutical Glass Packaging Materials(Trial)>and<Technical Guidelines for the Compatibility of Chemicals and Elastomer Seals(Trial)>.This article focuses on the above-mentioned guidlines and elaborate the various guiding principles from the perspective of drug applicants in order to give some direction to the drug research and development personnel.