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De Jong Pharma Consult

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Responsible Person

Expert Responsible Person (RP) & GDP Consultant – Your Compliance Partner in Pharma Distribution

As an experienced Responsible Person (RP), I ensure that your pharmaceutical distribution operations meet all the 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 medicinal products throughout the supply chain.

At DocMorris N.V. and KRKA Netherlands B.V., I have served and currently serve as the designated RP while also acting as a hands-on GDP Consultant. In these roles, I have successfully led critical QMS improvement projects following Health Authority inspections. My work includes writing and implementing procedures, closing compliance gaps, raising GDP awareness, and delivering targeted training sessions. Thanks to this approach, KRKA achieved a smooth Health Authority inspection outcome with only minor remarks—demonstrating the effectiveness of a well-prepared system.

The value of this work is best described by clients themselves. As Sonja Thüllen, Chief Pharmacist at DocMorris, shared:

“After a challenging Health Authority inspection, we needed an experienced Responsible Person that could support our company into better Good Distribution Practices compliance. We found Boudewijn to be the solution to our problem. Functioning and being registered as RP himself, he led by example while providing guidance and training to our other RPs. Now, after two years, we are stronger, better and ready for the future. It was a pleasure and a great experience to work with Boudewijn!”

One of my recent engagements was with Euromedica Limburg B.V., where I played a key role in preparing the organization for a GDP inspection. This included conducting internal audits as GAP assessments, contributing to process risk analyses, training staff in inspection behavior, and managing back-office support during the inspection. Post-inspection, I led a comprehensive QMS improvement project to address identified weaknesses, write and implement GDP-compliant procedures, and embed a stronger culture of quality across the organization.

Previously, at Reckitt Benckiser ENA B.V., I worked as Deputy RP, managing essential elements of GDP compliance including deviation and change control, supplier audits, hauler quality oversight, and QA support. My expertise lies not just in meeting regulatory expectations—but in building sustainable, audit-ready systems that add long-term value.

Need a certified Responsible Person or support preparing for your next GDP inspection? Get in touch..

Archive

  • June 2025
  • May 2025

Categories

  • Responsible Person
  • Supplier Audits
  • When Audits Turn Hostile: A Lesson in GMP Compliance
  • Enforcing GDP Compliance: A Responsible Person’s Unforgettable Lesson
  • The Cat in the Warehouse: When Pest Control Goes Feline

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Bedrijfsinformatie

De Jong Pharma Consult
Wipmolen 2
2964 HR Groot-Ammers
Nederland

KvK: 65982568

Contact informatie

phone: +31 412 712 000
cell: +31 6 18 49 39 56

De Jong Pharma Consult 2025 By Themespride