While the regulations require Brand Owners to establish specifications for all raw materials and for the finished product, based on the number of FDA Warning Letters that continue to cite this issue, this task appears to still be overlooked by the Brand Owners. For the contract manufacturing organization to make a supplement that meets the Brand Owner’s needs and is regulatory compliant, the Brand Owner has to take an active role in setting the specifications.
This whitepaper, Setting Specifications – Don’t Forget To Do This!, will help the Brand Owner understand why setting specifications are important and how to go about setting them.
