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On May 8, 2025, the European Medicines Agency (EMA) released a concept paper proposing revisions to Part IV of the EU Guidelines on Good Manufacturing Practice (GMP) specific to Advanced Therapy Medicinal Products (ATMPs). The proposed revisions focus on several key areas: Alignment with Revised Annex 1: The updated Annex 1, effective since August 2023, introduced modifications in the manufacture of sterile medicinal products. The revision seeks to harmonize ATMP-specific GMP requirements with these changes, ensuring consistency across guidelines. The revised guidelines will emphasize also the development and implementation of a comprehensive CCS, as outlined in the updated Annex 1. Integration of ICH Concepts: The revision plans to incorporate principles from ICH Q9 (Quality Risk Management) and ICH Q10 (Pharmaceutical Quality System), promoting a systematic approach to quality risk management and establishing a robust pharmaceutical quality system. Adaptation to Technological Advancements: The revision acknowledges the emergence of new technologies in ATMP manufacturing, such as automated systems, closed single-use systems, and rapid microbiological testing methods. The guidelines will provide clarifications on qualifying, controlling, and managing these technologies to prevent detrimental impacts on product quality. Updates on Cleanroom and Barrier Systems: The revised guidelines will offer further clarifications on expectations for cleanroom classifications and the use of barrier systems like isolators and Restricted Access Barrier Systems (RABS), while maintaining provisions for biosafety cabinets due to the manual manipulations associated with individualized ATMP batches. Legal References and Definitions: With the publication of new regulations on the quality and safety standards for substances of human origin intended for human application, the revision will update legal references and definitions related to starting materials of human origin. This is an important step, as the current version was adopted in November 2017. The public consultation period for this concept paper is open from 8th May to 8th July 2025. Stakeholders are encouraged to submit their comments via the EU Survey tool provided by the EMA. Read the full concept paper on the revision of Part IV Guidelines on Good Manufacturing Practice specific to Advanced Therapy Medicinal Products on the official website of the EMA.
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