One of the most fundamental concepts in the dietary supplement regulation dictated in 21 CFR 111, Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, is the role of the Quality Unit (QU). The QU is responsible for reviewing and approving all controlled processes and documentation; as well as making all disposition decisions for raw materials, packaging components, labels, in-process materials, and finished dietary supplement products. It is therefore essential that these quality responsibilities are clearly defined and assigned to appropriate personnel. This can be readily accomplished with a designated QU department at a single firm. However, the dietary supplement industry is an industry of contractors. Own Label Distributors (OLDs) often use multiple contractors to manufacture product, package and label product, test product, and then hold and distribute product to consumers. Given this complexity, the assignment of QU responsibilities can become quite confusing and even entirely lost. The establishment of a Quality Agreement among the contractors can resolve this by defining the QU obligations and responsibilities of each party involved. Learn what constitutes a Quality Agreement and how to establish one with your contractor in the EAS Webinar, Quality Agreements in the Complex World of Dietary Supplements.
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