Comment from MASIHUDDIN JAIGIRDAR

Please note that the current SUPAC guidance for Manufacturing Equipment Addendum has only information on equipment and operating principles. It has nothing to do about the very needed scale-up principles and scale-up factor for making larger batches in the larger equipment for the commercial production. 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 for commercial production. For these very important and much needed Scale-up Principles and Strategy Factors; 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 into the new SUPAC Guidance then it will remain the old SUPAC guidance that did not help either the industry or the OPQ/OPMA reviewers.