Dear Members
VERY IMPORTANT ( The LAST DATE OF SUBMITTING COMMENTS IS JULY 13, 2026.)
Please note FDA by a Notice on 03/03/2026 announcing the opening of a public docket to solicit information and comments on the Agency's series of guidances for industry on scale-up and postapproval changes (SUPAC) for specific dosage forms.
To Submit either electronic or written comments on the notice by June 1, 2026 to ensure that the Agency considers your comment on these guidance documents before it begins work on any revisions.
Docket No. FDA-2026-N-0809 for "Recommendations on Scale-Up and Postapproval Changes Guidances for Industry
FOR FURTHER INFORMATION CONTACT:
Ashley Boam, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 4192, Silver Spring, MD 20993-0002, 301-796-6341, [email protected].
I did contact her and put my not only some comments but also my practical experience on this issue to her in an email. I also indicated since the time line has passed I would like to put those comments and my recommendations through her to put into the new addendum to be published. On Friday 5/12/26 she sent me an email with the following.
"The public docket has been reopened for another 30 days so you can post your comments there now. Thanks for your patience. "
On receiving her email I did post my comments and suggestions into the FDA docket.
Following is my comments:
Comments: Please note that the current SUPAC guidance for Manufacturing Equipment Addendum has only information on equipment and operating principles. It has nothing about the needed scale-up principles for making batches in the larger equipment.
However, you need to put the actual Scale-up principles and Strategy into this new SUPAC guidance for Manufacturing Equipment Addendum. Otherwise, the firms would repeat the same mistakes when scaling-up their approved submitted exhibit batch to larger equipment.
The much needed Scale-up Principles and Strategy those I have included after each equipment section captioned in italics. Please note once the guidance is finalized and these scale-up principles and strategies are not included then it will remain the old SUPAC guidance that did help neither the industry nor the CMC reviewer.
Please note I have also attached a document for their consideration. In that you will find I have added the scale-up principles and factors in italics and red after each process and equipment.
Now I thought why not share with you people who are engaged professionally either in the academy or industry and use the SUPAC guidance. You may use it or give your thoughts into this document before it is finalized.
Please know the last date for submitting new comments is due 07/13/2026 at 11:59 pm EST.
Thanks
Masih Jaigirdar