Batch Number (Lot Number)
A unique identifier assigned to a specific production run of a pharmaceutical product. Batch numbers enable traceability — if a quality issue is discovered, the affected batch can be identified and recalled. Batch numbers appear on product labels and certificates of analysis.
Technical Context
Batch/lot numbers encode manufacturing information: typical formats include production date codes, sequential numbers, facility identifiers, and product codes. Traceability: batch numbers link the finished product to: raw material lots (amino acids, excipients, solvents), in-process records (synthesis, purification, formulation parameters), quality control test results (COA), equipment used, personnel involved, and environmental monitoring data during manufacturing. Regulatory requirements: batch production records must be retained for at least 1 year beyond product expiry date (or longer per local requirements). In case of quality issues: the batch number enables identification and recall of all units from the affected production run. Serialisation (unit-level unique identifiers) provides even more granular traceability under FDA DSCSA and EU FMD requirements, enabling tracking of individual product units through the supply chain.