Batch release testing in pharmaceutical manufacturing is a critical analytical process aimed at verifying the compliance of a specific batch or lot with predefined quality specifications, standards, and regulatory requirements prior to its distribution or use. This process encompasses a comprehensive series of tests, assays, and inspections conducted on representative samples to evaluate the product’s quality, safety, efficacy, and consistency against established acceptance criteria. Batches that meet these criteria are approved for sale or distribution, while those that do not conform are subject to further investigation, disposition, or corrective actions to rectify any deficiencies. This ensures that only pharmaceutical products that fully comply with all necessary specifications and quality standards are released, maintaining high levels of product integrity and patient safety.
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