ISSN 0377-9556 (PRINT)
ISSN 2383-9457 (ONLINE)
ISSN 2383-9457 (ONLINE)
| CQA Variables | Hardness (kg) | Drug contents (%) | Drug release at 2 hr (%) | Drug release at 24 hr (%) | |
|---|---|---|---|---|---|
| API | Purity | Low (1 |
Low (2) | Low (1) | Low (1) |
| Particle size | Low (1) | Low (1) | Mid (4) | Low (2) | |
| Solubility | Low (1) | Low (1) | Low (2) | Low (2) | |
| Binder | Type | Low (2) | Low (2) | Low (2) | Low (2) |
| Viscosity | Low (2) | Low (2) | Mid (4) | Mid (4) | |
| Ratio | Low (2) | Low (2) | Mid (4) | Mid (4) | |
| Sustained release agent | Type | Low (1) | Low (2) | High (18) | High (27) |
| Amount | Low (1) | Low (2) | High (18) | High (27) | |
| Disintegrating agent | Type | Low (1) | Low (2) | Mid (6) | Mid (6) |
| Amount | Low (1) | Low (2) | Mid (6) | Mid (9) | |
| Lubricant | Amount | Mid (4) | Low (2) | Mid (4) | Low (2) |
| Drying | Time | Mid (8) | High (18) | Mid (4) | Mid (6) |
| Temperature | Mid (8) | High (18) | Mid (4) | Mid (6) | |
| Tableting | Pressure | Mid (6) | Low (2) | Mid (4) | Mid (12) |
*RPN: Low (1~3), Middle (4~12), High (13~27)
Any variable above the RPN threshold of 13~27 was considered as potential high risk factor