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.