31 August 2022

EMA has published 3-year work plan for the Quality domain

EMA has published a three-year plan of the GMDP Inspectors Working Group (IWG). Plan focuses on a network and regulatory science strategy, considering supply chain integrity and resilience, product quality and the impact of new manufacturing technologies on the supply chain. The work plan includes specific activities to achieve an objective as well as routine activities that contribute to the overall strategic objective:

  • enhance traceability, oversight, and security in the human/veterinary medicine supply chain
  • enhance inspector capacity building at EU and international level;
  • reinforce the responsibility for product quality by harmonising and reinforcing guidance;
  • encourage supply chain resilience and review long-term risks resulting from dependency on limited number of manufacturers and sites;
  • analyse the possible implications of new manufacturing technologies in order to regulate the new supply chains needed;
  • catalysing the integration of science and technology in medicines development.

The plan also includes revise some of the EU guidelines:

  • EU GMP Chapter 1, Pharmaceutical Quality System.

Submission of a final text for the revised chapter to the European Commission to encourage industry to adopt risk-based approaches to prevent shortages, taking into EU GMP account initiatives such as the HMA-EMA Taskforce and industry inter-association guidance.

  • EU GMP Chapter 4, Documentation and Annex 11, Computerised Systems

Submit the final texts for the amended Chapter and Annex to the European Commission to ensure data integrity in the context of GMP.

  • EU GMP Annex 4, Manufacture of Veterinary Medicinal Products other than Immunological Veterinary Medicinal Products

Review comments received during stakeholder consultation on the concept paper and draft updated text. Submission of a final text to the European Commission.

  • EU GMP Annex 5, Manufacture of Immunological Veterinary Medicinal Products

To review comments received from concept paper stakeholder consultation and to provide the European Commission with a final text.

  • Annex 15, Qualification and Validation

Review the Annex with regard to new technologies in installations, products and processes and consider whether updates are required. Based on the Nitrosamines Lessons Learnt Exercise (LLE) recommendations, consider whether the scope can be extended to APIs.

  • Annex 16, Certification by a Qualified Person and Batch Release

Following the LLE recommendations, consider revising the Annex to provide additional guidance on batch traceability.

  • GMP and Marketing Authorisation Holders

Revise the paper in line with the LLE recommendations to provide guidance to MAHs regarding appropriate quality agreement with manufacturers.

  • ICH Q9: Quality Risk management

To support the EU members of the Expert Working Group (EWG) in developing the training materials on ICH Q9 with particular emphasis on risk identification and risk management, in liaison with the dedicated PIC/S expert circle.

  • ICH Q12: Lifecycle management

To support the EU members of the Expert Working Group (EWG) in developing the training materials on the guideline with particular emphasis on GMP inspection and Pharmaceutical Quality System aspects, in liaison with PIC/S initiative.

  • ICH Q7: GMP for Active Substances

To support the EU members of the Expert Working Group (EWG) in developing the guideline and following up on LLE recommendations to make Annex 15 mandatory for API through inclusion in Q7.

  • ICH Q13: Continuous Manufacturing

To support the EU members of the Expert Working Group (EWG) in developing the guideline.