Decentralised manufacture: UK Guideline on Good Manufacturing Practice (GMP)

AI Summary

This guidance from the UK Medicines and Healthcare products Regulatory Agency (MHRA) establishes the framework for Decentralised Manufacturing (DM), covering Point-of-Care (POC) and Modular Manufacturing (MM). Under the Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025, any organization performing these activities must establish a UK-based 'Control Site' holding a valid manufacturing license. The Control Site is responsible for all remote manufacturing locations, which must be documented in a Decentralised Manufacturing Management File (DMMF). Main regulatory concerns focus on maintaining oversight across geographically separated sites, ensuring data integrity, and preventing cross-contamination in shared facilities. The guidance emphasizes that a robust Pharmaceutical Quality System must be in place to manage equipment maintenance, staff training, and the onboarding or decommissioning of remote units. Required actions for companies include submitting DMMF dossiers for assessment, providing annual updates on all remote site activities, and ensuring a Qualified Person or Quality Controller maintains ultimate responsibility for product release. For POC products with short shelf lives, specific local release procedures are required to ensure safety before administration. MHRA inspections will be risk-based, evaluating the Control Site’s management procedures and physically inspecting a representative selection of operational remote sites to confirm consistent product quality and compliance with safety standards.