Hello all, I have a question that I didn't see anywhere on the microbiology side of the forums. We are going to switch microbiological testing methods from USP to FDA BAM for aerobic plate count (APC) and yeast & mold. How many samples should we run in a validation test--would 10 be enough? We want to run side-by-side comparisons of new vs. old using some of our most problematic (high APC).
We have about 100 different ingredients that we use and 256 different finished products that we manufacture. We manufacture dietary supplements in the United States under 21 CFR Part 111, 117, and 121, and are SQF food safety certified.
Thank you,
Matthew