Batch Release Testing
Any facility that will conduct European batch release testing must be identified in the Marketing Authorization Application (MAA) for the product.
FDAS is a skilled contract testing laboratory that can handle all of your necessary quality control testing to release a medicinal batch for sale.
Within the European Union (EU), there is a regulatory requirement that each batch of a marketed product is tested by an EU accredited cGMP testing laboratory against the approved product release specification of the Marketing Authorisation (MA).
FDAS works with customers to minimise the time from manufacture to availability by the patient.
Batch Release Services
- Commercial product batch release of marketed products
- QP services
- QP sample inspection
- Retained sample storage
Finished Product Tests
- Dissolution
- Disintegration
- Residual solvents
- Related Substances & Impurities
- Potency / Assay
- Physical / Chemical
- Microbial Limits Test
- Analytical Method Transfer
Industry