ERC The Netherlands B.V. received thirteen deficiencies from a recent inspection, one of which was classified as a critical deficiency.
These were mainly related to five main components:
- Quality and safety of starting materials. Inspection of chemicals and consumables is insufficient.
- The quality and safety of the final product is not guaranteed. The product is not sufficiently defined and characterized.
- The effectiveness of a gama irradiation step, and therefore the safety of the product, is not guaranteed.
- The change for the transition from Contractor 1 to Contractor 2 for gamma irradiation of cells has not been carried out as referred to in the GMP for ATMPs.
- Prevention of (cross) contamination is not sufficiently guaranteed.
- The environmental monitoring program and personnel monitoring are inadequate.
Reviewing this together with Emergent’s 483 (and resulting actions) starts to define a set of concerns in the ATMP world.
Investigations of a Dog 