Number of Validation Batches Needed To Ensure a Future Batch Produced After a Successful Stage 2 PPQ Has Over 95% Probability To Pass Potency Specification
| Process | Model Parameters (α, β) | Number of Validation Batches Needed (n) |
|---|---|---|
| 1 | B (1.5, 25) | 480 |
| 2 | B (25, 1.5) | 4 |
| 3 | B (1, 1) | 18 |