Dietary Supplements cGMP Compliance

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.

Our services in Dietary Supplements cGMP Compliance include:

• Drafting Standard Operating Procedures and revisions
• Conducting cGMP audits
• cGMP Training programs on 21 CFR part 111 subparts A-P (on-site, off-site or on-line) (See also USA on-line GMP training program)
• Quality Assurance Person training
• Quality assurance for the assessment and release of finished products for sale
• Developing stability protocols
• Preparation and review of Finished Product Specifications, Master Manufacturing Records and Batch Records
• Investigation of complaints, deviations and non-conformances
• Label review and control
• FDA Establishment Inspection Reports (EIR)
• Responses to FDA Warning Letters and 483 inspectional observations
• Develop lab and supplier/supplier qualification systems

dicentra’s qualified staff can serve as either your formal Quality Assurance personnel, or simply as your advisor on all matters related to cGMPs.