Lead Auditor

Professional Pharmaceutical Auditor Services

Regular auditing is essential for maintaining GDP and GMP compliance. I provide independent, thorough audit services that identify gaps before regulators do. Whether you need internal audits of your own systems or supplier audits to ensure your distribution chain meets standards, I deliver actionable findings and practical recommendations.

With 10 years of experience in pharmaceutical quality assurance, I've conducted numerous audits across the industry. My approach is practical and constructive—focusing on helping you improve rather than just finding problems.

Audit Services

• Internal GDP/GMP audits
• Supplier audits and qualification
• Pre-inspection readiness audits
• Gap analysis audits
• Process audits
• Documentation reviews
• Corrective action follow-up
• Audit training for staff

Why Regular Audits Matter

MHRA inspections can happen at any time, and being caught unprepared can result in serious consequences including warnings, fines, or suspension of your WDA(H). Regular internal audits ensure you're always inspection-ready and catch issues before they become major problems.

What a GDP audit covers

A GDP audit works through the areas the EU GDP Guidelines set out: the quality system itself, personnel and the Responsible Person arrangements, premises and equipment, documentation, operations including qualification of suppliers and customers, complaints and returns, outsourced activities, self-inspection, and transport.

The useful part is rarely the checklist. It is whether the records show the system running on ordinary days, not only on the day of the audit. Temperature excursions that were closed without investigation, a supplier approved on a certificate nobody rechecked, a deviation log that stops halfway through the year: those are the findings that matter, and they only appear if you look at evidence rather than procedures. The ground is covered in the GDP audit checklist for UK wholesalers.

Internal and self-inspection audits

GDP requires a self-inspection programme. Running it with someone outside the business has an obvious advantage: findings do not have to survive an internal conversation before they are written down.

Supplier and customer qualification audits

Qualification is a GDP requirement, and paper qualification is where supply chains tend to be weakest. An audit tests whether a supplier does what their documentation claims. The approach is set out in supplier qualification for GDP.

Pre-inspection readiness audits

An MHRA inspection tests the same system an audit does, with consequences attached. Doing it first, while there is still time to act, is the cheapest version of the exercise. What inspectors look for is described in preparing for an MHRA inspection, and the GDP and GMP distinction in GDP versus GMP.

What you receive

A written report covering scope and what was examined, findings each tied to the requirement they relate to and graded by severity, and observations that are not findings but are worth knowing. Findings are written to be closeable: the gap described, not the regulation quoted back. Where you want it, I stay involved through corrective action rather than handing over a report and leaving.

Common questions

What is the difference between GMP and GDP auditing?

GMP auditing looks at manufacturing operations. GDP auditing covers wholesale distribution: storage, transport, qualification of suppliers and customers, and the quality system around them. Both sit in the same supply chain and I audit to either.

How often should internal GDP audits be carried out?

GDP requires a self-inspection programme carried out to a defined schedule. Annually is the common baseline, with higher frequency for higher-risk areas or newly changed systems. The schedule should follow from risk rather than habit.

What happens during a supplier audit?

A supplier audit assesses whether that supplier meets the GDP or GMP requirements relevant to what they do for you. It covers their quality system, premises, procedures and records, and produces findings you can act on as part of qualification.

What do I receive at the end of an audit?

A written report setting out scope, what was examined, and each finding with the requirement it relates to and its severity. Findings are written so they can be closed, which means describing the gap rather than restating the rule.

Can an audit be done before an MHRA inspection?

Yes, and that is one of the most common reasons companies ask. A pre-inspection audit tests whether the quality system does in practice what the documents say, while there is still time to act on the answer.

Do you audit to ISO 9001 and ISO 13485 as well?

Yes. Internal audit against ISO 9001 or ISO 13485 is covered under ISO consulting. Note that an independent consultant prepares you for certification; certification itself is granted by an accredited certification body.

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.