Dietary Supplement Quality Agreement Template

Many of these considerations are good business practices, which are common to many sectors. What has developed in the food supplement industry since the GMP rules came into force in 2008 and were introduced in 2010 is the addition of a detailed quality agreement, an annex document to the wage-making agreement itself. Previously, quality and compliance were often compromised by a single clause or paragraph, resulting in the contract manufacturer agreeing to provide products that comply with all relevant provisions. “While each is important in its own way, these two agreements unite to ensure more fluid cooperation.” A quality agreement with a contract manufacturer is one of the things an FDA inspector would look for when he or she enters the operation of a trademark holder, said Larisa Pavlick, vice president of regulation and compliance at the United Natural Products Alliance. Prior to embarking last year with the organization, Pavlick worked for a few years as an FDA inspector in the Denver office. In her experience, she said that things changed around 2013, because so many times, when inspectors looked at operations on the brand owner`s side or in turn controlled a controlled fabrication, fingers were shown back and forth when one wondered who was responsible for what, when it came to keeping mass production documents. , load products, etc. The answer was this: the goat stops at the owner of the mark, but both parties have obligations in the GMP chain of responsibility. “You state that you do not have a written agreement with your contract manufacturer, that you have not conducted a test or that you have carried out any other activity to determine the manufacturer`s acceptance of the manufacture of your dietary supplements or to guarantee the quality of the dietary supplements received, and that the products are packaged and labelled in accordance with the manufacturing evidence.” Continues the letter.

Remember that the contract manufacturer (or packer, distributor, laboratory) is your partner and is responsible for the quality of your dietary supplement, but it is always your responsibility to ensure and confirm that your product is manufactured in accordance with all GMP requirements. One of the key ways to protect your interests and ensure that a GMP-compliant product is to define the responsibilities of your company and your contractual partners in a written and approved quality agreement. Confidence, transparency, traceability — these three Ts have dominated the conversation in the food supplement industry in recent years, especially after the New York Attorney General`s case appeared more than a year ago. The ubiquity of order fulfilling in this sector complicates this issue; What do you say publicly about the practices of the contract manufacturer, when the natural tendency is to regard these agreements as proprietary information? Some wage manufacturers make their enthusiasm for quality agreements a point of differentiation.