山东省药品生产技术转让过程中的常见问题分析

Discuss on the common problems of drug technology transfer in Shandong Province

本文根据国家药品监督管理局有关文件和现阶段山东省已开展的药品技术转让情况,结合日常技术审评经验,从证明性文件、处方工艺研究、质量对比研究、稳定性研究等方面遇到的几个常见问题进行分析,并对申请人如何避免在药品生产技术转让过程中出现相关问题给出了建议,以期降低转让过程中存在的风险,确保药品技术转让前后品种质量的一致性。

This paper analyzed the common problems in drug technology transfer,such as proof document,research of prescription and technology,quality comparison,comparative study on the stability and so on,based on relevant regulatory documents,completed work of drug technology transfer in Shandong Province and daily evalution experiences.In order to reduce the risks in the transfer process and ensure the quality consistency of the technology transfering products,we give some suggestions on how to avoid related problems in the drug technology transfer.