Question
I have been asked to do a quality audit of a label manufacturer whose products are used on beverages and food packaging. They are currently asking to be audited using 21CFR211 (pharmaceuticals). Is there another standard that is more appropriate for their product?
Answer
21CFR211 is the FDA regulation for cGMP for finished pharmaceuticals. This regulation does not apply to the labeling of food and beverages. The proper FDA regulation is 21CFR101. I suggest that you first start on the FDA web page on food labeling and nutrition.
John G. Surak, PhD
Surak and Associates
Clemson, SC
A member of Stratecon International Consultants
www.stratecon-intl.com/jsurak.html
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