WHO: Final Points to Consider in Continuous Manufacturing
The World Health Organization (WHO) has published the final version of its Points to Consider in Continuous Manufacturing of Pharmaceutical Products. The document is intended to support manufacturers and regulatory authorities in the implementation and regulatory assessment of continuous manufacturing and complements existing international guidance, in particular ICH Q13.
The guidance outlines the key GMP and regulatory considerations for continuous manufacturing throughout the product lifecycle. It covers topics including process design, control strategy, material traceability, process dynamics, continuous process verification (CPV), quality risk management and regulatory considerations for implementing or transitioning to continuous manufacturing. The document also emphasises the importance of science-based process control and a thorough understanding of process behaviour.
The final version remains largely consistent with the consultation draft and mainly includes clarifications and editorial refinements.
Unlike ICH Q13, the WHO document is not intended as a detailed technical guideline but rather as a practical reference to facilitate the adoption and regulatory assessment of continuous manufacturing, particularly in jurisdictions where specific regulatory guidance is not yet available.
Source:
WHO: TRS 1067 - Annex 2: WHO points to consider in continuous manufacturing of pharmaceutical products
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