A recent FDA 483 observation highlighted in GMP Trends Issue 1155 notes a critical lapse in batch identification, underscoring the risks of inadequate traceability in drug production.
During the inspection, investigators found that this drug manufacturing firm failed to assign unique batch numbers to its products. Instead, two different formulated products were assigned the same batch number, leading to a serious traceability issue. While the firm documented formulation numbers or product codes internally, this information was not included on product labels. As a result, the batch number on the product label could correspond to multiple product batches with different formulations.
Interestingly, the firm did not adhere to its own SOP titled “Lot No, Manufacturing Date, Expiry Date Assignment,” which explicitly requires the assignment of a unique batch number for each manufactured batch. The 483 reads as follows:
….. The drug product is not identified with a lot or control number that permits the determination of the history of the manufacture and control of the batch.
Specifically, manufactured drug products lack traceability as two different formulated products are assigned the same batch number. The firm documents the formulation number or the product code on each batch, however, this information is not printed on the product label. The product label has only batch number listed that can be traced back to multiple product batches with different formulations. The firm failed to follow its SOP …, “Lot No, Manufacturing Date, Expiry Date Assignment” that requires a unique number to be assigned for each batch manufactured at the site.
FDA mandates strict batch identification practices. According to 21 CFR 211.130, labeling must ensure proper identification, including unique batch numbers for traceability. Similarly, ICH Q7 (for API manufacturers) emphasizes the need for clear batch numbering to ensure product history can be easily determined.
Batch traceability is essential for product recall effectiveness in order to quickly trace and recall affected batches if a safety concern arises. A non-unique batch number would complicate the recall process, increasing risks to patients. In addition, if a quality deviation occurs, a firm must determine the source of the issue, meaning ambiguous batch numbers would hinder root cause analysis and corrective actions. Enforcing SOP diligence, enhancing labeling practices, and conducting GMP training is just the start of a non-exhaustive list to avoid similar observations.
This FDA 483 observation serves as a stern reminder that failing to assign unique batch numbers can lead to compliance violations, product recalls, and, ultimately, patient harm. By reinforcing robust traceability practices, manufacturers can ensure product integrity and uphold patient safety.
