Document Purpose: The purpose of this procedure is to establish the tool for self-inspection and second party audit requirements to ensure that the facility is fulfilling US FDA regulations as indicated in USA Department of Health and Human Services Food and Drug Administration 21 CFR Part 111, final rule guidance document on “Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements”.

Document Code: QA-130

Number Of Pages: 70