Validation Batch
Validation Batch. Means a batch of approximately 580 kg of API, but in no event less than 450 kg of API, produced pursuant to Section 3.8 and the Validation Protocol.
Found in
VIROPHARMA INC contract
Validation Batch. A batch of saleable product manufactured prior to NDA approval to confirm that the process set forth in the NDA is reproducible at commercial scale, and which meets FDA requirements for a validation process
All Definitions
Found in
ACHIEVE LIFE SCIENCES, INC. contract
