Supplier Qualification for GDP
Supplier qualification is a GDP requirement. Learn how to assess and approve suppliers to maintain compliance.
Under GDP, you must only obtain medicines from licensed suppliers within the authorised supply chain. Supplier qualification is the process of assessing and approving suppliers to ensure they meet required standards.
Why Supplier Qualification Matters
Qualified suppliers help ensure:
- ✓Products meet quality standards
- ✓GDP compliance is maintained throughout the supply chain
- ✓Risk of counterfeit medicines is minimised
- ✓Regulatory requirements are met
The Supplier Qualification Process
Step 1: Initial Assessment
Gather information about the supplier: company details, licences held (WDA(H), Manufacturer's Licence), history, and scope of activities.
Step 2: Documentation Review
Request and review: GDP/GMP certificate, quality agreement, QMS overview, recent inspection reports, and product authorisations.
Step 3: Risk Assessment
Evaluate risk based on: supplier location, product type, previous issues, criticality of products, and regulatory history.
Step 4: Supplier Audit
For higher-risk suppliers, conduct on-site audit to verify: premises, storage conditions, quality systems, personnel, and GDP compliance.
Step 5: Approval & Ongoing Monitoring
Grant approval based on assessment. Implement ongoing monitoring through: regular reviews, trend analysis, and re-qualification at defined intervals.
Key Documentation Required
- ✓Copy of WDA(H) or manufacturer licence
- ✓GDP/GMP certificate (from MHRA or equivalent)
- ✓Quality agreement / Technical agreement
- ✓List of products supplied
- ✓Insurance certificates
Red Flags to Watch For
- • No valid WDA(H) or manufacturer's licence
- • Reluctance to provide documentation
- • Prices significantly below market rates
- • Poor or no regulatory inspection history
- • Unusual supply chain routes
Need Help with Supplier Qualification?
I can help develop supplier qualification procedures, conduct supplier audits, and ensure GDP compliance.