Dietary supplements cGMP compliance is a requirement under FDA regulation 21 CFR part 111, which states that any person who manufactures, packages, labels, or holds a dietary supplement must establish and follow current Good Manufacturing Practices (cGMPs) to ensure the quality of the dietary supplement.
To ensure dietary supplement cGMP compliance, FDA performs on-site inspections and audits for all parts of 21 CFR part 111. Any facility directly impacted by 21 CFR part 111 is encouraged to prepare in advance for an FDA inspection as the FDA does not give prior notice before arriving for an inspection.
cGMP regulations state that quality control personnel must ensure that your manufacturing, packaging, labeling, and holding operations ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record (MMR). dicentra can help fulfill this vital requirement/role on your behalf.
dicentra’s qualified staff can serve as either your formal Quality Assurance personnel, or simply as your advisor on all matters related to cGMPs.