Table 1 Probable CMA’s, CPP’s and CQA’s of freeze-dried product development
Critical material attributes (CMA’s) | Critical process parameters (CPP’s) | Critical quality attributes (CQA’s) |
|---|---|---|
Buffer | Shelf temperature | Cake appearance |
Surfactant | Freezing ramp rate | Reconstitution time |
Fill volume | Freezing temperature | pH |
Total solid content | Hold time for freezing | Residual moisture content |
Ionic strength | Chamber pressure at primary drying | Potency |
Configuration of vial | Ramp rate to primary drying hold | Concentration of solution |
Stopper | Primary drying temperature | Particulate matter |
− | Hold time for primary drying | Content uniformity |
Ramp rate to secondary drying hold | Drug impurity | |
Secondary drying temperature | Sterility | |
Hold time for secondary drying | − |