Number of Batches
New Drugs 3 Batches, same facility
New Drug Stability Guideline
At least three batches and preferably more should be tested to allow for some estimate of batch-to-batch variability and to test the hypothesis that a single expiration dating period for all batches is justifiable.
Testing of a single batch does not permit assessment of batch-to-batch variability, and testing of two batches provides an unreliable estimate.
Additionally, degradation may not be uniform in/among batches. The sample tested may not be the worst case.
AADA 3 batches, same facility
ANDA 1 batch, same facility
- typically will need multiple batches to generate (develop) a Master Formula and to file the application
- biobatch must be a stability
We are here to help and guide you.