5 strategic goals and the activities to achieve them have been identified:

1. Enhancing supply chain oversight and security

• Improve EudraGMDP database records for better information sharing.
• Collaborate with the expert group for inspectional procedures for the inspection of the repositories system.
• Implement new Veterinary Regulation in the context of GDP.
• Explore GDP inspector training curriculum development (may be in collaboration with PIC/S).

2. Building inspector capacity

• Support international inspection programs.
• Harmonise guidelines with PIC/S.
• Increase MAHs' responsibilities regarding nitrosamines and supervision of API manufacturers.
• Enhance assessor-inspector joint inspections.

3. Reinforcing the resposibility for product quality

• Develop EU data integrity guidance in collaboration with WHO and PIC/S.

4. Encouraging supply chain resilience and reviewing long-term risks resulting from dependency on limited number of manufacturers and sites

• Identify sites for cooperative supervision between member states and strategic partners of these sites.

5. Analyse implications of new manufacturing technologies to regulate the new supply chains

• Continued integration of science and technology in medicines development
• Collaborate with the Quality Innovation Group (QIG) for innovation support.
• Evaluate decentralised manufacturing concept in GMP Guide.

Planned updates to the EU GMP Guide include aspects of data integrity, novel veterinary medicines, nitrosamines and the extension of the scope of Annex 15 to APIs.

Source:

EMA: GMP/GDP Inspectors Working Group

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