Dietary Supplement Consulting and Auditing

Auditing

NSF-DBA’s auditors and consultants have been auditing the dietary supplement industry’s quality and manufacturing operations for years before the Food and Drug Administration released the final rule 21 CFR 111 Dietary Supplement Good Manufacturing Practices in 2007. We have the experience in identifying gaps companies may have against the regulations, while also providing guidance on how to remediate any potential nonconformances. Our auditors can provide a variety of auditing services, including a standard check list-style audit, a full week consultative-type audit to a mock FDA audit. Our auditing and consulting professionals have decades of auditing experience and the expertise to perform audits for any type of activity within the dietary supplement industry. Our capabilities span across processes; from marketing and labeling to contract manufacturing. Our capabilities also span across products; from dietary ingredients to dietary supplement finished products. Our highly qualified staff is comprised of former dietary supplement or major pharmaceutical company senior corporate compliance auditors.

21 CFR 111 Gap Audits

Our experienced auditors can perform consultative gap audits at your facility against current 21 CFR 111 Dietary Supplement Good Manufacturing Practices (cGMPs). A check list-style audit report will be provided, including recommendations for the remediation of identified gaps found during the audit.

Vendor Qualification Audits

We can assist you in the search for your ideal quality vendors and suppliers by performing a third- party audit on your behalf against 21 CFR 111 cGMPs. Following the audit, a detailed report is provided highlighting the potential partner’s strengths, vulnerabilities, possible remedial actions and our overall recommendations on the suitability of the contractor based on your needs.

Benchmarking Audits

Our constant exposure to large and small dietary supplement companies worldwide enables us to assess your facilities, procedures and practices against current industry norms and best practices. We can partner with you to assess your current position in the marketplace and provide sound advice regarding your future direction.

Mock Regulatory Audits

We regularly assist clients in their preparation for an imminent regulatory inspection. Our experienced auditors will ‘mock’ the role of regulatory inspectors by performing the inspection as would be expected from actual FDA auditors. Following the audit, you will be provided with an in-depth and impartial assessment of your current state of compliance, a prioritized action plan to address noncompliancy and vulnerability and an understanding of the types of questions which would likely occur during the inspection with expert coaching on the most effective ways to respond to the questions.

Due Diligence Audits

We regularly assist dietary supplement companies, food companies and investment banks during the due diligence process for potential acquisitions, buy-ins, joint ventures and other investment projects. We perform an in-depth assessment of the regulatory compliance status of companies and/or projects by reviewing: status of marketing approvals, applications, etc.:

• Current complaints and adverse reactions, in order to assess vulnerability
• Current relationships with the major regulatory authorities
• Quality of staff in key technical positions
• General levels of GMP compliance
• Investment required to maintain GMP compliance in the short, medium and long term

Resources

• Learn more about NSF’s Certification Programs
• Download the Stability Testing Guideline for Dietary Supplements
• Download the Sourcing Guide for Dietary Supplement Manufacturers and Suppliers
• Download the SOP Template Resource Book