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Release

A crucial component of the cGMP manufacture is the quality control (QC) release testing of each batch. With each GMP batch, specific critical quality attributes (CQAs) of the drug substance or drug product need to be demonstrated and are required to fall in a required specification range.
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Test procedures and acceptance criteria for new drug products

Guidance regarding the release of drug substances is provided in ICH Q6 Test procedures and acceptance criteria for new drug products, which include:

  • Appearance and description

  • Identity

  • Purity and impurities

  • Potency

  • Quality

  • General/compendial tests

We collaborate closely with our clients to determine appropriate Strength, Identity, Safety, Purity and Quality (SISPQ) analytical methodologies to be used for their drug product release to meet regulatory expectations. Our laboratories release over 440 clinical or commercial batches of drug substance/drug product every year using over 2,800 batch release assays.

QC testing resources

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