On July 27, 2021, ICH published the long-awaited draft of the Q13 Guideline on Continuous Manufacturing of Drug Substances and Drug Products.
The purpose of the guideline is to provide legal and scientific considerations for the design, implementation and operation of continuous manufacturing. In addition to batch definitions, the document describes the different approaches to continuous manufacturing and provides guidance on control strategy and approval issues.
The new guideline ICH Q13 Continuous Manufacturing of Drug Substances and Products covers active ingredient and drug production manufacturing as well as the production of therapeutic proteins and combined or integrated active ingredient and drug production.
ICH Q13 aims to:
- harmonize the principles of continuous manufacturing, focusing on the specific elements of GMPs
- present flexible approaches for the development and implementation of continuous manufacturing
- provide guidance to industry and regulatory authorities for process evaluation.
The current status of the document corresponds to Step 2 of the ICH process and is open for comment. At this stage, the draft guideline, based on comments received from the ICH Expert Working Group (EWG), is distributed to regulatory authorities in the ICH regions for review in accordance with national or regional procedures. An EWG meeting is scheduled in November 2021 to discuss the comments received. The final guideline is expected to be signed in November 2022 (Step 3).