Table 7. Failure mode effects analysis (FMEA) for the different MEB, ALB and TNZ drug product quality attributes.

#	Critical quality attributes (CQA)	Failure mode	Failure effects	Severity	Occurrence	Detectability	Risk priority number (RPN)
1	Identity	No (intended) active ingredient in the sample or mislabeling (incorrect, inadequate or incomplete identification)	Treatment failure, death due to untreated disease	10	1	5	50
2	Assay	Under-dose, over-dose	Treatment failure, toxicity due to over-dose, drug resistance due to underdose	8	8	8	512
3	Disintegration	Inability to sufficiently disintegrate within the specified time period	No or poor absorption and bioavailability thus leading to treatment failure and resistance	6	1	5	30
4	Dissolution	Inability to sufficiently dissolute within the specified time period	Poor absorption and bioavailability thus leading to treatment failure and resistance	7	6	8	336
4	Dosage uniformity	Non-uniform distribution of dose/content within the individual dosage units	Sub-optimal therapy for a patient taking the sub-standard dosage unit only once and resistance	6	6	4	144
5	Friability	Tablets weight loss due to distribution or any other logistic related factors	Sub-optimal therapy due to loss of the active ingredient	2	1	1	2