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 and preparedness they need. Conducting these on a regular basis helps your business stay in the low risk category for 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 and Human Medicines Regulations 2012

• QMS effectiveness

• SOP completeness and execution

• Documentation control, deviations, and CAPAs

• Facilities, security, and storage controls

• Transport, returns, and recall procedures

Each audit concludes with a detailed written report highlighting:

• Areas of non-compliance

• Opportunities for system improvement

• Examples of 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

• Manufacturers, importers, and suppliers

• Document management and cold-chain logistics partners
  

• Mock MHRA Inspections

Our mock inspections are conducted exactly as MHRA GDP Inspectors would, simulating:

• Arrival and opening meeting

• QMS walkthrough

• Record sampling

• Staff interviews and process tracing

• Closing meeting with verbal feedback

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

This service includes a written gap analysis report and corrective action roadmap, giving your RP and senior team the tools needed to prepare effectively.

What Makes Our Audits Different?

• Conducted by former MHRA GDP Senior Inspectors

• Over 2,000 inspections completed across the UK and EU

• Actionable insights—more than just theory

• Links directly with our QMS design and SOP review services

• Drives real operational improvement and regulatory resilience

What We Cover

• GDP compliance against MHRA and EU GDP Guidelines

• Review of your QMS, CAPA system, SOPs, and training matrix

• Environmental controls and equipment validation

• Documentation audit trail and record-keeping

• Supplier and customer qualification

• Stock traceability and temperature control

• IT systems, eQMS platforms, and transport oversight

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

• When onboarding new staff or an RP

• As part of WDA licence application or renewal

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