Responsible Person & GDP
Responsible Person (RP) Services
Your compliance partner in pharmaceutical distribution: GDP-compliant assurance of integrity, quality, and traceability throughout the supply chain.
As an experienced Responsible Person (RP), I ensure your pharmaceutical distribution activities comply with all requirements of the EU Good Distribution Practice (GDP) guideline (2013/C 343/01). With a strong track record in implementing and overseeing GDP-compliant quality management systems (QMS), I help companies safeguard the integrity, quality, and traceability of medicines throughout the entire supply chain.
At DocMorris N.V. and KRKA Netherlands B.V., I have served and continue to serve as the designated RP, while also acting as a GDP consultant. In these roles, I have successfully led critical QMS improvement projects following Health Authority inspections: writing and implementing procedures, closing compliance gaps, raising GDP awareness, and delivering targeted training. Thanks to this approach, KRKA passed a Health Authority inspection with only minor observations.
At Euromedica Limburg B.V., I played a key role in preparing for a GDP inspection: conducting internal audits as gap assessments, contributing to process risk analyses, training staff in inspection behavior, and providing back-office support during the inspection. Following the inspection, I led a comprehensive QMS improvement project to address identified weaknesses.
Earlier, at Reckitt Benckiser ENA B.V., I worked as Deputy RP and managed essential aspects of GDP compliance: deviation and change control, supplier audits, quality oversight of carriers, and QA support.
After a challenging Health Authority inspection, we needed an experienced Responsible Person to help our organization achieve better Good Distribution Practice compliance. We found the solution to our problem in Boudewijn. Acting and registered as RP himself, he led by example while mentoring and training our other RPs. Now, after two years, we are stronger, better, and ready for the future.