This would be a good discussion with your review division; however, I have been successful with 1 full scale and 2 pilot lots. What would be your post approval commitment? Please note that the paradigm for 3 batches is no longer the target; at least 3 batches and it is dependent on your product and process.
Just some food for thought,
Dar
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Darlene Rosario MBA, RAC
Principal Consultant RA, Quality and Compliance
Velocity Consulting
Ventura CA
United States
Original Message:
Sent: 11-10-2015 09:21
From: Ed Lin
Subject: Batch Size of Lyophilized Injection Powder Finish Product
Dear All:
Does anyone knows that the batch size of ANDA/NDA submission
Batches as mentioned in 2014 FDA Guidelines be "at least 3 batches
of no less than 50L" for any vial size smaller than 2mL? This is quite a
size for pre-approval batches because they are going to be thrown
away after product approval.
Ed Lin
Quality and Compliance
United Biomedical, Inc., New York
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