Quality control release testing in the pharmaceutical industry involves conducting a comprehensive series of analytical tests, assays, and inspections on finished products, batches, or lots to ensure they meet predefined quality specifications, standards, and regulatory requirements prior to their distribution or use. This process assesses product quality, purity, potency, identity, and safety based on established acceptance criteria. Following this rigorous evaluation, products that comply are approved and released for sale or distribution, whereas nonconforming items undergo further investigation, disposition, or corrective actions to rectify any deficiencies. This critical step guarantees that only pharmaceutical products that fulfill stringent quality criteria reach the market, safeguarding patient safety and product efficacy.
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