BRCGS certification requirements and FDA dietary supplement regulations are separate frameworks. In dietary supplement operations, confirm that activities fall within the applicable certification scope and separately address dietary supplement requirements, including supplier approval, traceability and product controls.
Key compliance areas to review in dietary supplement operations
Define products and activities within certification scope
Confirm whether the site manufactures, packs, stores, or distributes products covered by its BRCGS certification scope. Do not assume certification covers every supplement activity.
Establish ingredient and supplier approval criteria
Maintain documented specifications, supplier qualification, risk assessments, approval status, and ongoing monitoring for materials used in products. See our guides to supplier and raw material approval and monitoring and specifications for raw materials, packaging and finished product.
Verify ingredient identity and traceability
Ensure ingredients can be traced from supplier and receipt through manufacturing and finished-product distribution. Establish lot identification, reconciliation, and investigation controls. More on traceability systems and product authenticity and integrity.
Review regulatory status separately from certification
For supplements, assess ingredient eligibility, NDI considerations, safety substantiation, labeling, and Part 111 requirements independently of certification.
Control changes and nonconformities
Evaluate changes in ingredient source, formulation, supplier, process, and specifications. Document deviations, product impact assessments, corrective actions, and effectiveness checks. See management of non-conforming products and corrective and preventive actions.
Maintain audit-ready records
Ensure procedures, specifications, supplier approvals, traceability records, training, and corrective actions are current and reflect actual operations. Our guide to document control and record-keeping explains how to keep them current.
How Consultare Inc. Group can help
Consultare can support BRCGS gap assessments for sites within the applicable scope, supplier approval, traceability, document control, internal audit preparation, and corrective action planning. BRCGS certification does not establish compliance with FDA dietary supplement requirements.
If you prefer to organize and manage your compliance activities yourself, you can also create a free SystemsBuilder account and begin building a structured system for your compliance documentation and processes.
Related services that support this topic
Depending on your facility, products and compliance needs, the following service areas may be relevant:
- BRCGS gap assessments and internal audits: review sites within the applicable scope and prepare for internal audits.
- Supplier verification support: strengthen supplier approval, specifications and ongoing monitoring.
- Document control services: keep procedures, specifications and records current and audit-ready.
- Corrective action support: plan corrective actions and effectiveness checks for deviations and changes.
- BRCGS and FDA compliance integration: address BRCGS and FDA responsibilities side by side.
Work with Consultare Inc. Group
Whether you are reviewing ingredient eligibility, supplier documentation, quality systems, or regulatory responsibilities, discuss your products, suppliers, documentation, and compliance priorities with the Consultare team. Contact the team or book a free consultation.
Technical sources and further reading
Editorial note: This content is educational. Specific requirements depend on product, facility, certification scope, and applicable rules.