Table 6 Failure mode and effect analysis for FDC ART/LUM tablet quality attributes
From: Quality of fixed dose artemether/lumefantrine products in Jimma Zone, Ethiopia
Critical quality attributes | Failure mode | Failure effects | Severity | Occurrence | Detection | RPN |
|---|---|---|---|---|---|---|
Identity | No (intended) active ingredient in the sample or mislabelling (incorrect, inadequate or incomplete identification) | Treatment failure, death due to untreated disease, toxicity | 10 | 7 | 4 | 280 |
Assay | Under-dose, over-dose | Treatment failure, toxicity due to over-dose, drug resistance due to under-dose | 8 | 7 | 7 | 392 |
Uniformity of mass | Non-uniform distribution of dose/content within the individual dosage units | Sub-optimal therapy for a patient taking the sub-standard dosage unit and drug resistance | 5 | 4 | 2 | 40 |