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Batch Release Testing

Any facility that will conduct European batch release testing must be identified in the Marketing Authorization Application (MAA) for the product.

Tentamus Pharma 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 UK, there is a regulatory requirement that each batch of a marketed product is tested by an accredited cGMP testing laboratory against the approved product release specification of the Marketing Authorisation (MA).

Tentamus Pharma 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 sample inspection
  • Retained sample storage

Finished Product Tests

  • Dissolution
  • Disintegration
  • Residual solvents
  • Related Substances & Impurities
  • Potency / Assay
  • Physical / Chemical
  • Microbial Limits Test
  • Sterility Testing
  • Analytical Method Transfer

Industry

  • Pharmaceuticals
  • Veterinary
  • Herbal Products

Products

  • Sterile
  • Non-sterile
  • Cytotoxic
  • Metered Dose Inhaler (MDI’s)
  • Veterinary
  • Herbal

    Tentamus laboratories in your vicinity