GDP Audits & Mock MHRA Inspections

Why Conduct a GDP Audit or Mock Inspection?

A GDP audit is more than a box-ticking exercise. It’s a proactive tool to:

• Identify gaps and help you implement the right processes to fill them

• Ensure your Quality Management System (QMS) is robust and fit for purpose

• Reduce the likelihood of new critical or major deficiencies during inspections

• Improve operational performance and regulatory compliance

• Train and prepare staff for real-life regulator interviews

Whether you're applying for a WDA(H), undergoing routine inspection, or managing a complex site, an audit or mock inspection gives your team the clarity, understanding and preparedness they need. Conducting these on a regular basis will help to your business stay in the ‘low risk’ category for regulatory inspections.

Our GDP Audit Services

We offer a range of flexible audit solutions tailored to your business model, risk profile, and operational maturity.

• Internal GDP Audits

Evaluate your own systems with fresh eyes. We assess:

• Compliance with Green Guide guidelines and guidance, Human Medicines Regulations 2012 and MHRA expectations

• QMS effectiveness

• SOP completeness and execution

• Documentation control, deviations, change controls and CAPAs

• Facilities, security, and storage controls

• Returns and recall procedures

• Warehouse Management Systems and stock control provision

• Quality Risk Management

• Effectiveness of outsourced activity oversight

• Self inspection process capabilities

• Training provisions

• Environmental controls and equipment validation/maintenance

• Supplier and customer qualification

• Stock management and traceability

• Temperature control/mapping/monitoring provisions

• IT systems and eQMS platforms

• Transport oversight and control

Each audit concludes with a written report highlighting:

• Areas of non-compliance

• Opportunities for system or process improvement

• Recommendations in relation to best practice

• Risk-rated recommendations aligned with MHRA frameworks
  

• Third-Party & Contractor GDP Audits

As a WDA holder, you’re responsible for ensuring your contracted and licensed service providers and suppliers operate compliantly. We conduct independent audits on your behalf, including:

• Storage and distribution contractors

• Couriers

• 3 & 4PL providers

• Suppliers

• Logistics partners

• Other contracted out service providers
  

• Mock MHRA Inspections

Our mock inspections are conducted in the same way as an MHRA inspection, simulating:

• Arrival and opening meeting

• Facilities walkthrough

• QMS review

• Record sampling, review and questioning

• Procurement, storage and supply provisions review

• Staff interviews

• Closing meeting with verbal feedback

This is your opportunity to experience an inspection that will help you build confidence in readiness for an MHRA inspection.

What Makes Our Audits Different?

• Conducted by former MHRA GDP Inspectors/Operations Managers

• Over 1500 regulatory inspections completed across the UK

• Links directly with our QMS design and SOP review services

• Drives real operational improvement and regulatory compliance

When Should You Schedule an Audit?

• Pre-MHRA inspection or reinspection

• As part of annual GDP self-inspection

• After a significant deviation, product recall, or CAPA

• As part of WDA licence application or renewal

• Following a major business change (e.g. site relocation, expansion)