上市后化学药品制剂生产场地变更政策解读与常见问题分析

Problems Analysis and Policy Interpretation in Chemical Preparations Site Change

目的 通过对已上市化药制剂生产场地变更政策解读和常见问题进行分析,为国内制药企业开展相关场地变更研究与质量管理工作提供参考。方法 对近年来出台的系列变更法规、技术指南进行深入解读,对已上市化药制剂生产场地变更中常见问题进行汇总分析。结果 上市药品变更贯穿于药品上市全生命周期,随着科学技术的进步,新原料、新工艺、新分析方法、新设备等新的科技成果都有可能被应用于药品的生产。其中药品生产场地变更是药品上市后变更的重要内容,是上市药品质量风险管理最具挑战性的一部分。结论 药品上市许可持有人作为药品上市后生产场地变更管理的责任主体,应当主动按照相关法规、指导原则的要求,开展药品上市后研究,实现全生命周期管理。

OBJECTIVE To provide reference for domestic pharmaceutical enterprises to carry out relevantchange research and quality management, based on analyzing the problems and interpretating the policy in the process of specific production site change. METHODS This paper deeply interprets a series of change technical guidelines issued in recent years, and summarized the common problems in the change of chemical preparations site. RESULTS The process change of listed drugs runs through the whole life cycle of drug listing. With the progress of science and technology, new scientific and technological achievements such as new raw materials, new processes, new analytical methods and new equipment may be applied to drug production. Among them, the change of drug manufacturing site is an important part of the change in the listing of drugs, which is the most challenging part of the quality risk management of listed drugs.CONCLUSION As the main body of drug manufacturing site change researches, marketing authorization holders should carry out drug production change research, complying with the requirement of series change technical guidelines, to realize the management through the whole life cycle of drug listing.