EMA: GMDP IWG Work Plan 2024 - 2026
The 3-year work plan for the EU GMDP Inspectors Working Group (IWG) aligns with Network Strategy and Regulatory Science Strategy (RSS) goals, emphasising supply chain integrity, product quality, and the impact of new manufacturing technologies. 10 documents of the GMP Guide will be revised or newly launched.
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.
|
EU GMP Guide |
Comment |
Target date |
|
Chapter 4 Documentation |
Amendment to assure data integrity (parallel to Annex 11) |
Q1 2026 |
|
Annex 11 Computerised Systems |
Amendment to assure data integrity (parallel to Chapter 4) |
Q1 2026 |
|
ATMP GMP Guidelines |
Review and update together with the Committee for Advanced Therapies (CAT) and the EC (new regulation on standards of quality and safety for substances of human origin, new Annex 1) |
Q4 2026 |
|
Annex 3 Manufacture of Radiophamaceuticals |
Review and update |
Q4 2026 |
|
Annex 4 Manufacture Of Veterinary Medicinal Products |
Review of comments recieved from concept paper consultation, draft an updated text |
Q1 2026 |
|
Annex 6 Manufacture of Medicinal Gases |
Review and update |
Q4 2026 |
|
Annex 15 Qualification and Validation |
Update in the context of new technology in facilities, products and processes and following up on Heads of Medicines Agencies‘ (HMA) nitrosamine recommendations, and extend the scope to APIs |
Q4 2025 |
|
Annex 16 Certification by a Qualified Person and Batch Release |
Update regarding HMA‘s nitrosamine recommendations |
Q4 2025 |
|
GMP for Novel Veterinary Medicinal Products |
Prepare final text |
Q4 2025 |
|
GMP for Autogenous Veterinary Vaccines |
Prepare final text |
Q4 2025 |
|
ICH Q12 Lifecycle Management |
Develop training materials on GMP inspection and PQS aspects together with PIC/S |
Q4 2025 |
Source:
EMA: GMP/GDP Inspectors Working Group
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