WHO: Draft Guidance on Continuous Manufacturing
The World Health Organization (WHO) has released a draft document titled Points to Consider in Continuous Manufacturing of Pharmaceutical Products for public comment.
This document outlines key considerations for manufacturers looking to implement continuous manufacturing processes in the production of finished pharmaceutical products, as well as excipients and active pharmaceutical ingredients (APIs).
WHO will review the feedback and aims to prepare a working document for potential adoption by its Expert Committee on Specifications for Pharmaceutical Preparations (ECSPP) in June 2025.
The draft covers topics including risk management, control strategies, process dynamics, validation of computerized systems, and testing for verification and stability. It also addresses both the advantages and challenges associated with continuous manufacturing.
The deadline for submitting comments is March 7, 2025.
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