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De Jong Pharma Consult

Your Quality Assurance Specialist

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Supplier Audits

Proven Expertise in Supplier Audits for the Life Sciences Industry

Supplier audits are a cornerstone of compliance in both EU Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) guidelines, as outlined in EudraLex Volume 4, Part I & II and the EU GDP guideline (2013/C 343/01). Regulatory authorities expect pharmaceutical and medical device companies to thoroughly qualify, audit, and monitor their suppliers to ensure product safety, quality, and traceability throughout the supply chain. These audits are not just formalities—they’re critical risk management tools that protect your patients and your business.

With over 650 supplier audits conducted across more than 30 clients in the pharmaceutical and medical device sectors, I bring two decades of hands-on experience to your supplier management program. My audits are tailored, risk-based, and aligned with current EU and global regulatory expectations. Whether you’re qualifying a new supplier, preparing for a Health Authority inspection, or strengthening your existing audit framework, I offer insights that go beyond checklists—focused on practical improvements and long-term compliance.

Whether working independently or as part of a global audit team, I deliver clear, pragmatic, and audit-ready reports that help improve supplier quality systems, mitigate risk, and prepare companies for regulatory scrutiny. I continue to conduct audits for long-standing clients like SQA Services and Pfizer, where consistent quality and reliability are essential.

Over the years, I’ve been privileged to receive positive feedback from peers and clients:

“Boudewijn is a very professional and knowledgeable Quality Auditor. He was hired several times as lead and co-auditor due to his wide range of expertise. All audits have been well prepared, and the audit documentation was available in a very short time. Thank you again for your great work and your auditing and empathetic skills.”
— Anja Zembrod, Global Supplier Qualification Auditor, AbbVie Deutschland

“Boudewijn turned out to be the ‘instant solution’ to support our supplier and internal audit team. Knowledgeable, time-efficient, and pragmatic: in compliance topics he knows how to separate the wheat from the chaff and has provided many good insights for continuous improvement. I’m sure we’ll be using Boudewijn again.”
— Mietje De Volder, Supply Chain Lead COVID Vaccines, Pfizer

“I can always count on Boudewijn for a fair assessment. He has a wealth of knowledge in GMPs and communicates clearly to deliver timely results. His skills go beyond auditing to offer real consulting insight. I look forward to further collaboration.”
— Nick Healy, Sr. Director of Client Success Management, SQA Services

By partnering with me, you’re gaining a seasoned professional who understands not only the regulations but also how to apply them effectively across diverse supplier types and geographies. I help clients establish supplier auditing programs from the ground up, refine existing systems, and ensure readiness for regulatory scrutiny.

Get in touch to ensure your suppliers meet the highest quality standards.

🔎 Contact me to schedule a supplier audit

Prefer to train your own staff to conduct supplier audits? Check out my 1-day Supplier Auditor Training course for pharma teams.

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