Issue link: https://www.e-digitaleditions.com/i/962670
Tablets & Capsules April 2018 32C M contract distributor. To ensure product quality and safety, each facility involved must comply with the appli- cable good manufacturing practices (GMPs) dictated in 21 CFR Part 11. This can be a challenge for a dietary sup- plement product owner, or own label distributor (OLD), because according to the FDA, the OLD is responsible for adhering to GMPs regardless of who actually carries out the individual operations [1]. A central tenet of these GMPs is that a quality unit (QU)—collectively quality assurance (QA) and quality The dietary supplement industry, like the pharmaceutical and food industries, relies heavily on contractors and subcontractors. However, no matter who does what along the supply chain, the product owner is ultimately responsible for GMP compliance. This article discusses how quality agreements can ensure compliance and what they should include. any dietary supplement products are manufactured by a contract manufacturer, packaged by a contract pack- ager, tested by a contract laboratory, and distributed by a The importance of quality agreements for dietary supplement manufacture Tara Lin Couch EAS Consulting Group outsourcing