batchexpiry

Batch expiry is the date assigned to a specific production lot indicating the time frame during which the product is expected to retain its identified quality attributes if stored under labeled conditions. After this date, the safety, identity, potency, or purity of the batch cannot be assured, and the batch should not be released for distribution or use. Batch expiry recognizes variability between production lots due to manufacturing, packaging, and materials, and it is distinct from the general shelf life of a product or the expiry date printed on individual units.

Expiry dates are established through stability studies conducted in accordance with regulatory and industry guidelines. Stability testing on representative production lots under defined storage conditions estimates how long quality attributes remain within specification. The results determine a shelf life, which is then used to calculate the batch-specific expiry date. In some cases, products also have retest dates for active ingredients or derived in-use stability requirements, reflected in labeling with storage and handling conditions.

Practically, batch expiry supports inventory control, traceability, and regulatory compliance. Labels, quality systems, and distribution records must reflect the batch number and expiry date. If a batch approaches or passes expiry, it is quarantined, re-tested if permitted, or discarded according to established procedures. Expired or improperly stored batches pose quality and safety risks and may require product recalls or regulatory notification.