GDP Consultant UK

Professional GDP Consultant Services

As an experienced GDP consultant with 10 years in pharmaceutical quality assurance, I help companies navigate the complexities of Good Distribution Practice (GDP) compliance. Whether you're establishing a new wholesale operation, need to improve existing systems, or preparing for an MHRA inspection, I provide practical, actionable guidance.

GDP compliance is not just about meeting regulatory requirements—it's about protecting patient safety and ensuring medicinal products maintain their quality throughout the distribution chain. I work with companies across the UK to build robust, efficient GDP systems that satisfy inspectors while being practical for everyday operations.

What I Offer

• GDP Quality System design and implementation
• Gap assessments and remediation planning
• SOP development and review
• GDP training for staff at all levels
• MHRA inspection preparation
• Ongoing GDP compliance support
• Responsible Person (RP) services
• Responsible Person Import (RPi) services

Why Choose a Freelance GDP Consultant?

Working with a freelance GDP consultant gives you direct access to senior support without the overheads of large consulting firms. I provide personalised attention to your specific challenges, flexible engagement models, and practical solutions drawn from real-world experience. You'll work directly with me—not a junior consultant or account manager.

What GDP actually asks of you

Good Distribution Practice is not a single rule but a set of chapters covering the quality system, personnel and the Responsible Person, premises and equipment, documentation, operations, complaints and returns, outsourced activities, self-inspection, and transport. Holding a WDA(H) means running all of them continuously, not demonstrating them once at inspection.

The distinction between GDP and GMP trips up more companies than it should, particularly those doing both. It is set out in GDP versus GMP.

Where compliance most often slips

In practice the same few areas account for most findings. Temperature control where mapping is out of date or excursions are closed without investigation, covered in pharmaceutical temperature control requirements. Supplier qualification carried out on paper and never revisited, covered in supplier qualification for GDP. Self-inspection scheduled but not completed. Deviations logged but not closed.

A working checklist for each area is in the GDP compliance checklist for UK wholesalers, and what inspectors look for is in preparing for an MHRA inspection.

How an engagement usually runs

Most start with a gap assessment, because it is difficult to plan remediation against an unclear picture. That produces a prioritised list: what must change before an inspection, what should change soon, and what is an improvement rather than a gap. From there the work is either building the missing parts of the system or strengthening what exists. Where you also need a named Responsible Person or independent audits, those run alongside.

Common questions

What does a GDP consultant do?

A GDP consultant helps pharmaceutical companies comply with Good Distribution Practice (GDP) regulations. This includes designing and implementing quality systems, preparing for MHRA inspections, providing Responsible Person services, and ensuring wholesale dealer operations meet regulatory requirements.

Do you offer GDP consultant services across the UK?

Yes, I provide GDP consultant services throughout the UK. Services can be delivered on-site or remotely, depending on your needs. I have experience working with companies of all sizes, from small wholesalers to large MAHs.

How much does a GDP consultant cost?

GDP consultant pricing varies based on the scope of work. I offer flexible arrangements including project-based pricing and retainer options. Contact me for a free consultation to discuss your specific requirements and get a tailored quote.

What's the difference between GDP and GMP?

GMP (Good Manufacturing Practice) applies to the manufacture of medicinal products, while GDP (Good Distribution Practice) applies to the wholesale distribution activities. GDP ensures that products are stored, transported, and handled in accordance with quality standards throughout the supply chain.

Which areas does a GDP audit or gap assessment cover?

The chapters the EU GDP Guidelines set out: quality system, personnel and the Responsible Person, premises and equipment, documentation, operations, complaints and returns, outsourced activities, self-inspection and transport.

We have had findings from an MHRA inspection. Can you help close them?

Yes. Remediation works best when the corrective action addresses the cause rather than restating the finding. That usually means tracing why the system allowed the gap, then changing the system and evidencing the change.

Official sources

• EU Guidelines on Good Distribution Practice (2013/C 343/01)
• MHRA — good manufacturing practice and good distribution practice
• Human Medicines Regulations 2012, Part 9

This page is general guidance, not regulatory advice. For advice on your specific situation, get in touch.