化学药品注射剂生产所用塑料组件系统相容性研究思路浅析

Compatibility study discussion of plastic components and systems used in manufacturing of chemical injection products

化学药品注射剂生产过程使用的塑料组件系统与药液接触后可能产生相关浸出物,进而影响产品质量甚至危害患者安全。结合国内外已发布的相关标准及指南,对化学药品注射剂生产用的塑料组件系统(如硅胶管、滤器等)相容性研究的一般思路进行介绍。认为制剂申请人作为责任主体,应基于风险评估及必要时的试验研究,确认化学药品注射剂生产中使用的塑料组件系统的适用性。总结了目前申报资料中发现的相容性研究存在的问题,以期为药品研发及生产企业提供指导和帮助。

Plastic components and systems used in the manufacturing of chemical injection products may lead to the accumulation of leachables,which could impact product quality or patient safety.Based on the published guidelines and standards,this article will introduce the recommended method for plastic component and systems compatibility studies(such as silicone tube,filter).Drug product applicants should be responsible for the suitability of plastic components and systems through risk assessment and experiments if necessary.The author also summarized several wrong methods found in the technical documents.The main objective of this article is to guide the applicant to implement compatibility studies with a scientific and reasonable manner.