人用药品技术要求国际协调理事会《Q13:原料药和制剂的连续制造》中停留时间分布介绍

Introduction to residence time distribution of ICH“Continuous manufacturing of drug substances and drug products.Q13”

自我国发布适用人用药品技术要求国际协调理事会《Q13:原料药和制剂的连续制造》的公告后,如何落地实施成为医药行业普遍关注的问题。停留时间分布和停留时间分布模型是该指导原则中用于连续制造物料追溯和支持分流策略而制定的重要工具。本文从停留时间、停留时间分布和停留时间分布模型的概念出发,详细介绍该指导原则的制定过程,对指导原则中关于停留时间分布的相关内容进行归纳总结,以帮助相关单位更好地理解指导原则及其中停留时间分布的规定和要求,助力连续制造技术在我国的落地实施。

Following the announcement by China of the adoption of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use(ICH)on“Continuous manufacturing of drug substances and drug products.Q13”,the implementation of this guidance has become a widespread concern in the pharmaceutical industry.The residence time distribution(RTD)and its mode serve as crucial tools outlined in the guidance designed for facilitating material traceability and support diversion strategies in continuous manufacturing.This article begins by introducing the concepts of residence time,RTD and its mode and then details the draft process of this guidance.The relevant sections on RTD are also summarized,aiming to enhance comprehension of the guidance and their associated requirements and thereby to aid in the successful implementation of continuous manufacturing technology in China.