As part of the Dietary Supplement CGMP Rule, FDA requires supplement manufacturers to follow specific procedures and record-keeping to ensure safe production. Manufacturers must prepare and follow several process controls, including written master manufacturing records (MMRs) for each unique formulation and batch size of supplements. In order to ensure each batch meets uniform specifications, FDA requires MMRs to outline aspects such as:
- Identifying information for the supplement, including properties such as concentration or strength of each ingredient for each batch size,
- Specifications for points in the manufacturing process that require controls to ensure quality of the supplement,
- Specific actions needed to implement and verify these controls,
- Corrective actions for when specifications are not met.
