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


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