Internal Audits & Self-Inspections – Strengthen Your Compliance from Within

Internal audits and self-inspections are essential tools for maintaining a robust pharmaceutical Quality Management System (QMS). Required under both EU GMP and GDP regulations, these audits ensure that every part of your operation—from warehousing to documentation—is functioning in line with current guidelines and is inspection-ready at all times. Far more than a checkbox exercise, effective self-inspections reveal hidden risks, drive continuous improvement, and demonstrate control to regulators.

With over 350 internal audits and self-inspections performed over the past 20 years for clients in the pharmaceutical and medical device sectors, I bring unparalleled insight into what makes an audit not only compliant but valuable. My approach is risk-based, tailored to your operations, and always aligned with EU and international regulatory expectations. Whether you need a fresh perspective on your processes, a readiness check before a health authority inspection, or support in training your internal auditors, I can help.

Internal audits done right don’t just satisfy regulators—they strengthen your quality culture, prevent deviations, and protect your license to operate.
If you want a reliable, experienced auditor who knows exactly what to look for—and how to fix it—contact me today to schedule your next internal audit or self-inspection.

Want to build internal audit expertise in-house? I also provide a practical, 1-day Internal Auditor Training designed for pharmaceutical teams.