VDI Expert Opinion VDI-EE 6306

Co-Initiator and Co-Author: VDI-EE 6306 as the New Foundation for Third-Party GMP Audits

In today’s increasingly global and complex supply chains, efficient, legally compliant, and practical solutions for GMP supplier audits are more essential than ever. With this in mind, the VDI-EE 6306 “3rd-Party GMP Audits – Supplier Audits in the Pharmaceutical Industry” was developed by an interdisciplinary team of experts under the leadership of the Association of German Engineers (VDI) – co-initiated and significantly co-authored by experts of Heacon Service GmbH, together with representatives from industry, consultancy firms, and regulatory authorities.

A Collaborative Work with Substance
The expert group included experienced professionals from the pharmaceutical industry, GMP auditors, quality assurance specialists, and members of the VDI Society for Process and Chemical Engineering (VDI-GVC). Our company contributed both practical expertise as a specialized audit service provider and key content regarding audit methodology, report usage, and regulatory classification.

Contributing authors include:

  • Representatives of leading pharmaceutical companies
  • GMP consultancy firms
  • Members of relevant pharmaceutical associations and institutions
  • VDI as the coordinating body

Why a New Guideline?
Regulatory expectations for GMP-compliant supplier audits continue to rise – as does the need for flexible yet robust audit models. With VDI-EE 6306, a structured framework now exists that clearly defines and supports the execution and regulatory acceptance of external “Third-Party” audits.

VDI-EE 6306 in Practice
The guideline provides:

  • Standardized guidance for audit planning, execution, and documentation
  • Clear requirements for auditor qualifications, independence, and methodology
  • Defined rules for confidentiality, data integrity, and the legally compliant use of audit reports
  • A regulatory foundation aligned with EU-GMP and GDP principles

As an ISO 9001:2015-certified GMP audit service provider, we consistently implement the principles of VDI-EE 6306 – in our processes, in the qualification and training of our auditors, and in the preparation of standardized, audit-ready reports.

Our Contribution to Industry Standardization
Our involvement in developing VDI-EE 6306 is not only a milestone for us – it reflects our commitment to actively shaping the future of quality assurance in pharmaceutical supply chains. Our shared goal was to establish a practical, compliant, and legally sound model for Third-Party GMP audits – benefiting pharmaceutical clients, suppliers, and regulators alike.

Conclusion: Third-Party GMP Audits with Confidence
VDI-EE 6306 provides pharmaceutical companies with a technically robust and regulatory-accepted tool to outsource GMP supplier audits in a structured and efficient manner – maintaining full compliance with minimal internal resource use.

Would you like to learn more about applying VDI-EE 6306 in your company or are you planning to implement a Third-Party GMP audit model?
Get in touch with us – we support you from strategy to execution with audits that are structured, standardized, and regulator-ready.

Do you still have questions?

We look forward to your message