福建省药品上市许可持有人委托生产中共线生产的存在问题分析

Problem Analysis on Drug Share-line Production of Fujian Province Marketing Authorization Holder's Commissioned Production

目的:旨在推进福建省药品上市许可持有人落实主体责任,提高持有人和生产企业共线生产质量管理能力,有效控制污染的风险,保障药品质量和用药安全。方法:归纳国外药品共线生产相关法规指南,分析福建省药品上市许可持有人委托生产检查过程中发现的共线生产问题和风险。结果:通过对缺陷问题的梳理分析,发现主要存在共线生产风险评估不充分、风险控制措施不到位、清洁验证相关缺陷和设备及文件控制方面等问题并提出相关建议。结论:本文可为进一步规范福建省药品上市许可持有人、药品生产企业对药品共线生产的科学管理,为有效降低药品共线生产过程中污染、交叉污染风险提供技术支撑。

Objective:To urge the drug marketing authorization holder in Fujian Province to implement the main responsibility,improve the holder and the manufacturer's share-line production quality management ability,effectively control the risks of contamination and to ensure the quality and safety of medicines.Methods:The requirements of relevant foreign laws and regulations on drug share-line production were summarized.The problems and risks of Fujian province MAH's share-line production found in the inspection process were analyzed.Results:By combing and analyzing the inspection defects,it was found that the main problems included inadequate risk assessment of share-line production,inadequate risk control measures,defects related to cleaning and verification,equipment and document control.This article proposes relevant suggestions to address the above issues.Conlcusion:This article provides technical support for further standardizing the scientific management of drug share-line production by drug marketing authorization holders and drug manufacturers,and eff ectively reducing the risks of contamination in the process of drug share-line production in Fujian province.