Summary of Results Obtained with FMEA and PHA for Non-conformities Identified by the FDA and EMA
| Non-conformity | Regulatory Agency | RPN | RRI |
|---|---|---|---|
| Quality agreements | EMA | 45 | 15 |
| Investigation into deviations | EMA | 27 | 15 |
| Failure to establish and follow adequate control procedures | FDA | 27 | 9 |
| Cleaning procedures | EMA | 15 | 15 |
| Complaint handling | EMA | 15 | 15 |
| OOS investigation and CAPA system | EMA | 15 | 15 |
| Raw material quality control | FDA | 9 | 9 |
| Failure to assure the quality of the drug product | FDA | 9 | 9 |