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Batch Release Testing

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

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