The European Medicines Agency (EMA) has published a concept paper (EMA/INS/GMP/48771/2025) outlining proposed revisions to Part IV of the GMP guidelines specific to Advanced Therapy Medicinal Products (ATMPs).
This revision aims to bring ATMP GMP guidance in line with the revised Annex 1 (effective August 2023) while integrating recent advancements in quality risk management (ICH Q9), pharmaceutical quality systems (ICH Q10), and Contamination Control Strategy (CCS).
Key highlights :
- Incorporate Quality Risk Management (QRM) and Pharmaceutical Quality System (PQS) principles from ICH Q9 and Q10.
- Clarifies use of closed systems, isolators, and RABS for contamination control
- Acknowledges the use of biosafety cabinets for individualized ATMPs.
- Incorporates new technologies like automated single-use systems and rapid microbiological methods.
- Updates references related to human origin materials based on recent EU regulations.