Most Common Non-conformities Committed by Manufacturers of Non-sterile Drug Products as Well as Their Likelihood of Occurrence, According to the FDA WLs and EMA NCRs
| Most Frequent Non-conformities | Source | Occurrence (%) |
|---|---|---|
| Your firm has not established written production and control procedures to assure that the drug products produced have the identity, strength, quality and purity they purport or are represented to possess. | FDA | 12 |
| Your firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed. | FDA | 10 |
| The written stability testing program is inadequate to assess the stability characteristics of drug products and for determining appropriate storage conditions and expiration dates. | FDA | 9 |
| Record integrity and veracity: some records were made up or altered. | EMA | 9 |
| There was a continued failure of the Quality Management System and Quality Assurance to establish compliance with EU GMP. | EMA | 8 |
| Lack of appropriate root causes investigation into deviations. | EMA | 6 |