Client & Dates
UK Clinical Research Organisation | January 2025
Client Challenge
A UK-based clinical research organization required independent verification of a key investigational medicines distribution vendor to ensure strict compliance with Good Distribution Practice (GDP) and Good Clinical Practice (GCP).
BethAri’s Role
Independent Lead GxP Auditor commissioned to conduct a comprehensive vendor requalification audit.
Approach
Audit protocol design, multi-day on-site facility and documentation audit in southeast England, cold-chain integrity review, quality management system evaluation, and risk assessment.
Deliverables
Audit plan, formal on-site audit report, non-conformance findings, and CAPA evaluation review.
Evidenced Results
Provided independent assurance of clinical vendor compliance, successfully closed audit findings through targeted CAPAs, and re-established vendor qualification status.
Contributing Experts
Dr Chinedu Madichie (Lead Auditor).