Internal Audits & Self-Inspections

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 every part of your organization — from warehousing to documentation — operates in line with current guidelines and remains inspection-ready at all times.

With more than 350 internal audits and self-inspections conducted over the past 20 years for clients in the pharmaceutical and medical device sectors, I bring unmatched insight into what makes an audit not just compliant, but genuinely valuable. My approach is risk-based, tailored to your operation, and always aligned with EU and international expectations.

Internal audits done well don't just satisfy regulators — they strengthen your quality culture, prevent deviations, and protect your manufacturing or distribution license.