A documented supplier approval process is a core requirement of Good Distribution Practice (GDP).
Wholesale distributors must demonstrate that medicinal products are sourced only from authorised, verified suppliers — with documented due diligence, risk assessment, and approval decisions.
During inspection, regulators such as the Medicines and Healthcare products Regulatory Agency will expect to see a structured and defensible supplier qualification process.
This template provides exactly that.
What This Template Helps You Do
- Document supplier authorisation checks (WDA(H), GDP status)
- Record inspection history and regulatory status
- Assess quality systems and temperature controls
- Evaluate transport and anti-falsification measures
- Risk-rate suppliers (Low / Medium / High)
- Formally approve, reject, or conditionally approve suppliers
- Maintain periodic review records
It turns supplier approval from a basic questionnaire into a structured, regulator-facing system.
Why It Matters
Common GDP inspection findings include:
- Incomplete supplier verification
- No documented risk assessment
- Lack of re-approval reviews
- Poor audit trail of approval decisions
A clear, documented qualification framework demonstrates:
- Risk-based thinking
- Active Responsible Person oversight
- Management control of the supply chain
- Ongoing compliance monitoring
Suitable For
- WDA(H) licence holders
- Responsible Persons (RP)
- QA & compliance managers
- Start-up wholesale distributors
- Organisations preparing for MHRA inspection
This editable Word template is designed to be implemented immediately and adapted to your licensed activities.
