Good Manufacturing Practice

Good Manufacturing Practices (GMP) are FDA-mandated quality standards (21 CFR Part 111) for the manufacturing, packaging, labeling, and storage of dietary supplements. GMP requirements include identity testing of raw materials, establishing product specifications for purity, strength, and composition, maintaining clean facilities, and keeping detailed production records. While GMP compliance is legally required, FDA inspection coverage is limited. Third-party GMP audits (by organizations like NSF International) provide additional quality assurance beyond basic regulatory compliance.