Comment from MASIHUDDIN JAIGIRDAR
AnonymousSupportIndividual
Summary: The commenter argues that the current SUPAC guidance for Manufacturing Equipment Addendum lacks specific scale-up principles and strategies for larger equipment. They provide a detailed technical framework for scale-up strategies across various pharmaceutical processes (e.g., milling, blending, granulation, drying) to be included in the new guidance.
Docket No. FDA-2026-N-0809 for “Recommendations on Scale-Up and Postapproval Changes Guidances for Industry
Comments: Please note that the current SUPAC guidance published in 2014 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.
Therefore, FDA needs 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.