ABSTRACT

The GMPs define quality to mean that the dietary supplements consistently meet their established specifications for identity, purity, strength, and composition, including limits on contaminants, and have been manufactured, packaged, labeled, and held under conditions to prevent adulteration (as defined in the FD&C Act). Quality control (QC) is defined as a planned and systematic operation or procedure for ensuring the quality of the dietary supplements, whereas the term quality control personnel refers to any person, persons, or group within or outside of the firm who has/have been designated to be responsible for the firm’s QC operations.