How To Prepare Your Warehouse For A WDA(H) Inspection

UK Wholesale Dealer's Authorisation (WDA(H)) MHRA authorisation required for covered wholesale distribution of human medicines in the UK. Inspections are a core part of MHRA’s oversight; preparation reduces the risk of findings, business interruptions and corrective action letters. This guide focuses on practical steps warehouse and fulfilment managers should take before, during and after a WDA(H) inspection.

Inspectors check that the site, systems and staff can deliver GDP-compliant distribution every day, not just during inspections. Preparation is operational: documented procedures, trained staff, validated temperature systems where applicable, accurate records and demonstrable control over quarantine and returns. Allocate time for a gap assessment well before any planned or routine inspection.

Pre-Inspection Checklist

• Licence Documents: Have the current WDA(H) authorisation and any correspondence with MHRA on site and accessible.
• Responsible Person Availability: Ensure the nominated Responsible Person and senior operations contact are available to meet inspectors and answer questions.
• SOPs and Training Records: Maintain up-to-date SOPs for receipt, storage, dispatch, returns, recalls and deviations, and file staff training evidence against each SOP.
• Traceability Records: Be ready to show batch-level receipt and dispatch records, reconciliation documents and inventory controls.

Premises And Security

Inspectors will assess whether the physical layout prevents contamination, mix-ups and unauthorised access. Check that segregation for quarantined goods is physically enforced, pest control logs are current, and security systems (access control, CCTV) are operational. For cold storage, ensure temperature alarms are tested and logs captured for the relevant period inspectors will review.

Temperature-Controlled Operations

Temperature excursions are a frequent inspection focus. Maintain validated temperature mapping, calibration certificates for monitoring devices and documented corrective actions for any excursions. Demonstrate end-to-end temperature control from receipt through to handover to carriers and during internal transfers. Provide evidence that contingency plans (generators, alternative storage, emergency contact lists) have been tested.

Record Demonstrations To Expect

• Batch Traceability: Show receipt records matching supplier batch numbers to dispatch records for recent consignments.
• Deviation Logs: Present records of deviations, root-cause analyses and corrective/preventive actions (CAPA).
• Recall Drill Evidence: If you’ve performed a mock recall, have the drill report, timelines and communications ready.

Common Inspection Findings And How To Avoid Them

Frequent findings include inadequate SOPs, incomplete training records, poor quarantine controls and insufficient traceability. To avoid these, conduct internal audits using MHRA guidance as the checklist, update SOPs to reflect actual practice, and retrain staff where gaps appear. A pragmatic approach is to align your internal audit schedule so that an audit precedes any expected MHRA visit by a few weeks to allow corrective actions to be closed.

During The Inspection

Designate a liaison to accompany inspectors and provide documentation. Be transparent and factual when explaining processes or deviations. If an inspector asks to observe an activity (receipt, quarantine or picks), ensure the process is performed to your SOPs; if a deviation occurs, document it immediately and show the corrective action plan.

After The Inspection

MHRA will issue findings or a report; classify each item by priority and assign owners. For critical findings, prepare a detailed CAPA plan with timelines and evidence of root-cause analysis. Communicate status to affected clients and, where appropriate, regulatory bodies. Keep a follow-up audit scheduled to verify corrective actions before an MHRA re-inspection.

In short, the UK Wholesale Dealer's Authorisation (WDA(H)) is the MHRA authorisation required for covered wholesale distribution of human medicines in the UK. Effective inspection readiness combines up-to-date documentation, robust temperature and security controls, a competent Responsible Person and active internal audit practices. These steps reduce regulatory risk, protect patient safety and keep fulfilment operations resilient.