cGxP

Consulting

 

 

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

 

 If you would like the full document electronically, please contact us at: support@cgxp.com or click Contacts

    If you have any questions, do not see documents pertaining to your area or would like further information about any of the documents, please contact us at: support@cgxp.com or click Contacts

    We are here to help and guide you.

Hit Counter