Quality Agreements in the Complex World of Dietary Supplements


One of the most elementary ideas in the dietary complement regulation dictated in 21 CFR 111, Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, is the function of the Quality Unit (QU). The QU is answerable for reviewing and approving all managed processes and documentation; in addition to making all disposition choices for uncooked supplies, packaging elements, labels, in-process supplies, and completed dietary complement merchandise. It is subsequently essential that these high quality tasks are clearly outlined and assigned to acceptable personnel. This will be readily completed with a chosen QU division at a single firm. However, the dietary complement business is an business of contractors. Own Label Distributors (OLDs) typically use a number of contractors to fabricate product, package deal and label product, check product, after which maintain and distribute product to customers. Given this complexity, the project of QU tasks can grow to be fairly complicated and even totally misplaced. The institution of a Quality Agreement amongst the contractors can resolve this by defining the QU obligations and tasks of every celebration concerned. Learn what constitutes a Quality Agreement and the right way to set up one along with your contractor in the EAS Webinar, Quality Agreements in the Complex World of Dietary Supplements.



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