Number of Validation Batches Needed To Ensure at Least 9 Out of 10 Future Batches Produced After a Successful Stage 2 PPQ Have Over 95% Probability To Pass Potency Specification
| Process | Model Parameters (α, β) | Number of Validation Batches Needed (n) | |
|---|---|---|---|
| Bayesian Method1 | Frequentist Method2 | ||
| 1 | (1.5, 25) | >480 | 29 |
| 2 | (25, 1.5) | 15 | 29 |
| 3 | (1, 1) | 26 | 29 |
↵1 Number of validation batches is determined such that at least 9 out of 10 future batches produced after a successful Stage 2 PPQ have over 95% probability to pass potency specification.
↵2 Number of validation batches is determined such that with 95% confidence that out of 10 future batches manufactured after a successful Stage 2 PPQ, the number of batches that pass specification is greater than or equal to 9.