21 CFR Part 111 - CGMP for Dietary Supplements

What it says

Dietary supplement manufacturers, packagers, labelers and holders must follow CGMP covering personnel, the physical plant, equipment, a quality control operation, production and process controls with master manufacturing records and batch production records, laboratory operations, holding and distribution, returned products, and complaints, with specifications established for components and finished batches.

Paraphrased for plain-language clarity. Always verify against the current published regulation text.

What it means in practice

• Part 111 reads more like drug CGMP than food CGMP, with a quality control unit, master and batch records, and specifications at its core.
• Identity of each dietary ingredient must be verified, and a firm cannot rely on a supplier's certificate of analysis alone without qualifying the supplier.
• Product complaints must be reviewed and investigated, and records kept.

What FDA inspectors look for

• Whether specifications are established and met for components and finished batches.
• Whether identity testing of dietary ingredients is performed as required.
• Whether master manufacturing records and batch production records are complete and followed.

Related regulations