The UK’s MHRA has released a 2025 guideline on Good Manufacturing Practice (GMP) for decentralised manufacturing (DM), ensuring safe, high-quality medicinal products at point-of-care (POC) and modular manufacturing (MM) sites. Key requirements include UK-based Control Sites holding MHRA licenses, robust Pharmaceutical Quality Systems (PQS) using Quality Risk Management (QRM), and tailored product release procedures for POC and MM products. The guideline emphasizes compliance for substances of human origin and shared facilities.

At EOSPA we can assist biopharma companies in navigating these complex DM regulations to achieve compliance and optimize manufacturing processes.