Introduction to residence time distribution of ICH"Continuous manufacturing of drug substances and drug products.Q13"
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.
continuous manufacturingresidence timeresidence time distribution
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