“Regulatory Compliance is Critical to our Mission.”
The Wellington Foods’ Quality System is based on both compliance with regulatory guidelines and industry best practice. As manufacturers of dietary supplements, Wellington Foods is regulated under 21 CFR Part 111 and 117.
This section of the Food and Drug Administration’s regulation governs Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements. It contains specific requirements for all aspects of our operation.
Process control is a central theme in the regulation. Our written Standard Operating Procedures give our process well defined structure and clear direction for all involved. They provide our team members with clarity and consistency in the daily workflow, and give customers and auditors a better understanding of the critical steps in our process. These written Standard Operating Procedures are also the basis of our employee training programs for both cGMP compliance as well as specific job function.
Testing is also a primary focus of 21 CFR Part 111 and 117.
Testing is required as a way of demonstrating control of incoming materials, manufacturing process and finished products. Testing provides confirmation of identity, purity, potency and composition for raw materials and finished products. We test materials both at our in-house Quality Control laboratory, and at outside contract laboratories.
Our regulatory compliance staff is also prepared to assist with customer quality audits, and regulatory agency audits. Our team conducts regular internal audits as well, to confirm that our process and the condition of our facility conform to our high standards.
As a contract manufacturer and the entity that affixes the label to a finished product, Wellington Foods shares responsibility with our customers for the information printed on the product label. A role of our Regulatory Compliance staff is to review customer supplied labels and provide feedback on the content. It is in our customer’s best interest, and the best interest of Wellington Foods to be confident that the information on the product label is correct and meets regulatory standards for dietary supplements. Our staff can be an important part of this process, however because we cannot offer legal advice, we always recommend that our customers seek an opinion from a qualified attorney before printing labels.
Regulatory standards for Organic, Gluten Free, Non-GMO, Vegan, Kosher and Halal can be complex.
The ability to offer customized formulations for Organic, Gluten Free, Non-GMO, Vegan, Kosher, Halal and other specialty products can provide your brand an advantage in a competitive marketplace. Our Regulatory Compliance team has experience working with the complex regulation and labeling requirements needed for these specialized products. We also work closely with the certifying agencies during product development to insure that our process and your finished products comply with the expectations of these agencies.
Wellington Foods has put substantial effort into meeting the high standards of regulatory compliance.
We invite you to schedule time with our staff to discuss the importance of regulatory compliance, and how our program can benefit your brand.