GMP Lot Release Testing at IBR Inc.

Lot release testing is of fundamental importance throughout the whole life cycle of pharmaceuticals, enabling to ensure product safety, efficacy and consistency between batches and supporting chemistry, manufacturing and control (CMC) activities. As an independent contract laboratory and an impartial party, IBR Inc. supports lot release testing by providing evidence of a guaranteed level of safety, efficacy and quality of the released product and ensuring that the product meets the given specifications.

IBR Inc. supports lot release testing of biologics, vaccines and small molecules by means of a broad panel of bioanalytical services. The facility performs potency assays, endotoxin testing, stability testing, container closure testing and other analytical methods and tests to determine the physicochemical properties of the product and offers diverse technology and methodologic solutions to face a variety of challenges related to lot release testing.

Find a summary of assays to support lot release visiting our webpage or tell us your specific requirements.

Our quality standards

Lot release at IBR Inc. is performed following the EU GMP requirements and the specifications for test procedures and acceptance criteria described in the ICH Q6 guidelines (Q6A for new drug substances/new drug products and Q6B for biotechnological/biological products categories, respectively) and in the ICH Q1A and Q5C guidelines for stability testing (Q1A for new drug and Q5C for biotechnological/biological products categories, respectively).

Please contact us to select the best solution tailored to your specific needs.