Batch Release Testing
Conformance testing required for release of finished product to the European Market. Within the European Union (EU), there is a regulatory requirement that each batch of a finished marketed product be tested by an EU accredited GMP testing laboratory against the approved product specification.
Source BioScience can provide full GMP chemical and microbiological analysis with a turnaround that compresses the time from product manufacture to availability to the patient.
With quality control laboratories for chemical and microbiological support we offer:
- A wide range of analytical resources
- Complete compendial analysis (BP, EP, JP and USP)
- Experience and expertise in batch release testing of products manufactured outside the EU
- IMP batch release testing and re-test
- Method transfer and analyst exchange
- FDA and MHRA audited laboratories
As an approved and accredited laboratory with a long history of batch release testing to the Medicines Testing Scheme, we provide a wealth of experience across a wide range of product types.
For further information and prices please contact us or call +44 (0)115 973 9012