U.S. GMP requirements are somewhat more prescriptive than their European and PIC/S counterparts.

Title 21, Part 211.192

Title 21, Part 211.192 of the Code of Federal Regulations (CFR) mandates that “any unexplained discrepancy or a failure of a batch or any of its components to meet any of its specifications shall be thoroughly investigated, whether or not the batch has been distributed.

Extended to Other Batches

The investigation shall be extended to other batches of the same drug product and any other drug products that may have been associated with the specific failure or discrepancy. A written record of the investigation shall be made and shall include the conclusions and follow-up.”

Consider Other Batches

This regulation requires investigations to consider not only the batch for which a problem has been identified, but also other batches and other products, which may also be affected by the issues to be identified. In addition, the regulations also require the investigation to include conclusions and follow-up.

The follow-up should include preventative actions and tracking to identify trends which may impact on the quality of the products manufactured.