US FDA/CFSAN - Implementation of FDA's Current Good Manufacturing Practices for Dietary Supplements
October 24, 2007
IFR
- Requirement for 100 percent identity testing of dietary ingredients is found at Subpart E - Requirement to Establish a Production and Process Control System, § 111.75 ''What must you do to determine whether specifications are met?'' in the CGMP final rule.
- 111.75(a)(1) Before you a component you must: (1) Conduct at least one appropriate test or examination to verify the identity of any component that is a dietary ingredient.