Validation for switching microbiological testing methods
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
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
Hi Matthew,
It depends on the reason/objectives for the switch and the specific methodological differences.
How do you anyway know which method is "correct" ? Such evaluations usually require use of reference samples whose micro. characteristics are reliably known, eg by acquiring additional data from external labs.
I don't know much about supplements or USP for that matter. However BAM was intended for food and cosmetics. USP is intended to be used for supplements, drugs, etc.
USP methods are intended for these more complex products that could cause false negatives, etc. Maybe this is a non issue for your products and apc & YM.
What is the reason for changing?
We were told by a scientist at a laboratory/consulting firm that USP methods were established in the 1800s for drugs such as injectables and this is why they might not be appropriate for dietary supplements. Also, these USP methods have requirements that suitability testing must be performed each time a new ingredient is tested--presumably because dietary supplements were not their original intended use. For these reasons we are looking to change.
We were told by a scientist at a laboratory/consulting firm that USP methods were established in the 1800s for drugs such as injectables and this is why they might not be appropriate for dietary supplements. Also, these USP methods have requirements that suitability testing must be performed each time a new ingredient is tested--presumably because dietary supplements were not their original intended use. For these reasons we are looking to change.
Hi matthew,
I suggest you also investigate microbiological proficiency testing aka ring tests.. There are a few discussions on the topic in earlier threads here.
We were told by a scientist at a laboratory/consulting firm that USP methods were established in the 1800s for drugs such as injectables and this is why they might not be appropriate for dietary supplements. Also, these USP methods have requirements that suitability testing must be performed each time a new ingredient is tested--presumably because dietary supplements were not their original intended use. For these reasons we are looking to change.
I understand. Can you get around suitability testing just by switching methods? Isn't method suitability defined in 111 part J?
i'm not trying to convince you not to switch. I just don't want you to do the wrong thing. Hopefully there is a another supplement person that can chime in. The scientist's logic does make sense to me.