The EMA's GMDP (GMP/GDP) Inspectors Working Group has released its 2024 -2026 Work Plan.
The document sets the priorities of the WG, split into strategic goals, tactical goals, operational/product-specific goals and lessons learned on nitrosamines.
In particular, the documents lists in the section 2.1 the guidelines-related activities for the upcoming years (non-exhaustive list):
| Guideline | Target date | Comments |
| GMP Guide: Chapter 4 (Documentation) |
Q1 2026 |
|
| GMP Guide: Annex 11 (Computerised Systems) | Q1 2026 |
|
| Guidelines on Good Manufacturing Practice specific to Advanced Therapy Medicinal Products | Q4 2026 |
|
| GMP Guide: Annex 15 Qualification and Validation | Q4 2025 | To provide the European Commission with a final text for an amended Annex 15 in the context of new technology in facilities, products and processes and following up on LLE recommendations, and extend the scope to APIs. |
| GMP Guide: Annex 16 Certification by a Qualified Person and Batch Release | Q4 2025 | To provide the European Commission with a final text for an amended Annex 16 following up on LLE recommendations. |
| GMP and Marketing Authorisation Holders | Q4 2025 | To revise the paper in line with recommendations from the Nitrosamines LLE, to strengthen guidance for MAHs in terms of having adequate quality agreement with manufactures |
| ICH Q12: Lifecycle management | Q4 2025 | 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. |
For more details, please refer to th below link.
Reference link: 3-year work plan for the Inspectors Working Group
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