VDI Expert Opinion VDI-EE 6306

Co-initiated and co-authored: VDI-EE 6306 as a new basis for third-party GMP audits

In an increasingly globalized and complex supply chain, efficient, legally compliant and practical solutions for GMP supplier audits are more important than ever. Based on this conviction, 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) – initiated and significantly co-authored by experts from Heacon Service GmbH together with representatives from industry, consulting and authorities.

A joint effort with substance
The expert group consisted of experienced specialists from the pharmaceutical industry, GMP auditors, quality assurance experts and representatives of the VDI Society for Process Engineering and Chemical Engineering (VDI-GVC). Our company not only contributed its practical perspective as a specialized audit service provider, but also provided key content on audit methodology, the use of reports and regulatory classification.

The co-authors include, among others:

• Representatives of leading pharmaceutical companies
• GMP consulting firms
• Members of the German pharmaceutical associations and institutions
• The VDI as a coordinating body
  

Why a new directive?
The regulatory requirements for GMP-compliant supplier audits are constantly increasing – as is the need for flexible yet robust audit models. VDI Expertise 6306 is the first structured framework that clearly defines the implementation and acceptance of external, so-called “third-party” audits and safeguards them from a regulatory perspective.

VDI-EE 6306 in practice
The guideline offers:

• Standardized specifications for audit planning, implementation and documentation
• Clear requirements for qualification, independence and methodology of external auditors
• Clear rules on confidentiality, data integrity and the legally compliant use of audit reports
• A basis for regulatory acceptance in line with EU GMP and GDP

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

Our contribution to industry standardization
Our involvement in VDI-EE 6306 is not only a milestone for us, but also an expression of our aspiration to play an active role in shaping quality assurance in the pharmaceutical supply chain. The aim was and is to establish a practical and legally compliant model for third-party GMP audits – for the benefit of pharmaceutical clients, suppliers and ultimately also the regulatory authorities.

Conclusion: Third-party GMP audits with backing
VDI-EE 6306 provides companies with a new, technically sound and regulatory compliant tool for outsourcing GMP supplier audits in an efficient and structured manner – without compromising quality, but with maximum compliance security.

Would you like to learn more about the application of VDI-EE 6306 or are you planning to start third-party GMP audits?
Contact us – we will accompany you from strategy to audit implementation.