Audit Third-Party Suppliers to Ensure Their GMP Compliance

Audit All Third-Party Suppliers for GMP Adherence

Remember: Never rely solely on documents—physically audit third-party suppliers to ensure full GMP compliance and product quality.

Why This Matters in GMP

Pharmaceutical companies depend on suppliers for APIs, excipients, packaging, and testing services. Relying on third parties without auditing them introduces risks such as substandard materials, data falsification, or contamination. GMP compliance must extend beyond the manufacturing site to every supplier in the chain. Regular audits verify quality systems, facility conditions, documentation practices, and regulatory history. They also ensure suppliers are aligned with product specifications and contract obligations. Skipping audits can result in quality issues, recalls, and regulatory enforcement. Supplier audits demonstrate control, risk mitigation, and commitment to product integrity.

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Regulatory and Compliance Implications

FDA 21 CFR Part 211.84 and 211.22 require supplier qualification and quality unit oversight. EU GMP Chapter 7 mandates supplier audits and quality agreements. WHO GMP and Schedule M stress vendor evaluation and documentation. Auditors often request supplier audit schedules, audit reports, and CAPA records. Failure to audit suppliers, especially for critical materials, is a major GMP deficiency. Auditing supports due diligence, regulatory compliance, and consistent product quality across the supply chain.

Implementation Best Practices

Maintain a supplier qualification program with risk-based audit frequencies.
Use structured audit checklists covering GMP systems, documentation, training, and facility conditions.
Document findings, assign CAPAs, and monitor implementation timelines.
Execute quality agreements outlining GMP responsibilities, documentation expectations, and deviation reporting.
Reaudit vendors after significant changes or compliance concerns.

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Regulatory References

FDA 21 CFR Part 211.84 – Component Testing and Vendor Qualification
FDA 21 CFR Part 211.22 – Responsibilities of Quality Unit
EU GMP Chapter 7 – Outsourced Activities and Supplier Qualification
WHO GMP – Vendor Audit Guidelines
Schedule M – Third-Party Supplier Audit Requirements