Overview of ICH Q13 Guideline for Continuous Manufacturing of Drug Substances and Drug Products

DOI
  • ITO Kosuke
    独立行政法人 医薬品医療機器総合機構

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Other Title
  • ICH Q13（原薬及び製剤の連続生産に関するガイドライン）の概要

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Description

<p> Continuous manufacturing attracted attention as an innovative manufacturing technology contributing to the stable supply of pharmaceutical products, and development of an internationally harmonized guideline for the implementation of continuous manufacturing was desired. ICH adopted a topic on the continuous manufacturing of pharmaceuticals in 2018, and the Guidelines for Continuous Manufacturing of Drug Substances and Drug Products (Q13) came into effect in Japan in May 2023. The ICH Q13 guideline applies to both drug substances and drug products for synthetic drugs and therapeutic proteins, and it consists of the main text and annexes. The main text describes the basic concept and points to be noted in the implementation of continuous manufacturing. The annexes contain illustrative examples and considerations specific to certain modalities. This article provides an overview of the ICH Q13 guideline, referring to the background and basic concepts (eg. scientific approach and regulatory considerations) described in the ICH Q13 guideline.</p>

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Details 詳細情報について

  • CRID
    1390584508741916544
  • DOI
    10.14982/rsmp.15.63
  • ISSN
    21890447
    21857113
  • Text Lang
    ja
  • Data Source
    • JaLC
  • Abstract License Flag
    Disallowed

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