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Vendor Qualification and Supply Chain
Supplier and Contract Manufacturer Audits, Desk Audits, and Documentation Review.
FDA Food Safety Modernization Act Supply Chain Programs review and implementation
Vendor Qualification
A strong supply chain program is essential for GMP compliance and product integrity, especially for FDA Consulting. I assist brands and manufacturers in building modern, risk-based systems that ensure every ingredient, supplier, and manufacturing partner adheres to FDA requirements and industry best practices, including Foreign Supplier Verification Programs (FSVP).
My services support the full lifecycle of supply chain control, from qualification through ongoing verification, providing practical solutions for any gaps or challenges encountered.
Supplier Verification and Approval includes on-site or desk audits, establishing documentation, and implementing testing and monitoring programs, all of which are integral to maintaining Good Manufacturing Practice (GMP).
For Ingredient and Component analysis, I provide written hazard and risk analyses in accordance with FDA Guidance, focusing on potential hazards and contaminants.
I can assist with qualification or requalification processes, which involve reviewing regulatory history, performance, and testing and monitoring programs to ensure proper verification of preventive controls.
Ingredient documentation support includes:
- Spec development
- Certificate of Analysis (CofA) establishment, review, or modernization
- Sampling plan implementation
- Establishing testing and monitoring programs
- Collaboration with third-party laboratories
Furthermore, I provide oversight of third-party or contract manufacturers, conducting GMP assessments and document reviews as part of comprehensive regulatory consulting.