EU-GMP Adjustments in the next Years

Recommendation

7/8 May 2024

KPIs and Quality Metrics - Live Online Training
How to foster Continual Quality Improvement

EMA has published a three-year plan. This plan of the GMDP Inspectors Working Group (IWG) focuses on a network and regulatory science strategy, taking into account 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. A large part of the IWG's work plan is derived from the Nitrosamines Lessons Learnt Exercise (LLE). 

The plan also includes plans to revise the EU GMP guidelines

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 account initiatives such as the HMA-EMA Taskforce and industry inter-association guidance.

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.

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.

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 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.

For further information, please see the EMA's "3-year work plan for the Quality domain".