GDP Audit Preparation: A Practical Guide for Wholesale Dealers

Storage Facility Qualification and Temperature Mapping

EU GDP Guidelines (2013) require that storage facilities are qualified, that the temperature distribution across the storage area has been mapped and confirmed as suitable for the products stored. Temperature mapping studies must be conducted under representative conditions, including worst-case seasonal conditions (summer and winter), and must cover all storage areas including loading bays, staging areas and refrigerated units.

Common gaps in temperature mapping programmes:

• Mapping studies conducted once at facility qualification but not repeated after modifications to HVAC systems, layout changes or equipment replacements
• Winter mapping only, many facilities only map in one season and extrapolate rather than measuring actual conditions
• Insufficient sensor density, the number and placement of temperature sensors must be sufficient to characterise the full storage environment
• Alarm limits not validated against the mapping data, alarms set based on product limits rather than the mapped temperature distribution
• Loading bay and staging areas excluded from qualification despite products spending time there

Continuous Temperature Monitoring

Ongoing temperature monitoring during storage and transportation is required under EU GDP Guidelines. Monitoring equipment must be calibrated at defined intervals, and calibration records must be maintained. Alarm systems must be functional, tested, with documented alarm responses, and must alert responsible personnel when excursions occur outside defined limits.

Temperature excursions must be documented, investigated and assessed for product impact. An excursion during transport does not automatically mean the product is compromised, but the assessment of product impact must be documented and must involve the marketing authorisation holder or manufacturer where required. Products held pending investigation must be appropriately quarantined.

Responsible Person Oversight

The Responsible Person (RP) for wholesale distribution is a named individual who holds personal accountability for GDP compliance at the licence holder. MHRA and other competent authorities increasingly scrutinise whether the RP is genuinely active in the role, not just a named individual who satisfies the qualification requirement.

Inspectors assess RP oversight by examining:

• Whether the RP has approved the GDP quality system and has meaningful oversight of changes to it
• Whether the RP reviews and approves product complaints, returns assessments and suspected falsified medicine reports
• Whether the RP is involved in self-inspection planning and outcome review
• Training and continuing professional development records for the RP
• Whether the RP has sufficient authority to reject non-compliant products and stop non-compliant activities

FMD Compliance and Falsified Medicines

Falsified Medicines Directive (2011/62/EU) requirements, specifically the Delegated Regulation (2016/161) on safety features, require wholesale dealers to verify the authenticity of serialised medicinal products and decommission packs at the point of sale or supply to end customers. Inspectors examine whether FMD verification processes are functioning correctly and whether suspected falsified medicines are handled and reported appropriately.

GDP inspections increasingly include review of FMD system connectivity, verification scan logs and the process for handling scan failures or alerts. Organisations should ensure their NMVS repository connection is maintained, scan failure rates are monitored, and there is a documented process for investigating and escalating FMD alerts.

Customer and Supplier Qualification

Wholesale dealers must verify that their customers are entitled to receive medicinal products, either as licensed wholesale dealers, pharmacies, veterinary practitioners or other authorised entities. This verification must be documented and maintained current. Equally, suppliers of medicinal products must be qualified as authorised holders of a manufacturing or wholesale dealer licence.

Inspectors examine the customer and supplier qualification records for currency, completeness and the process for re-verification when licences expire or are modified. A customer or supplier whose licence has lapsed without the wholesale dealer's knowledge is a GDP compliance failure regardless of whether the products supplied were themselves legitimate.