VDI Expert Opinion VDI-EE 6306

In an increasingly globalised and complex supply chain, efficient, legally sound and at the same time practical solutions for GMP supplier audits are more important than ever. Out of this conviction, 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) – initiated and substantially co-authored by experts of Heacon Service GmbH together with representatives from industry, consulting and authorities.

A collaborative work of 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). In this, our company contributed not only the practical perspective of a specialised audit service provider, but also central content on audit methodology, report usage and regulatory classification.

The co-authors include, among others:

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

Why a new guideline?

The regulatory requirements for GMP-compliant supplier audits are continuously rising – as is the need for flexible yet robust inspection models. With the VDI expertise 6306, a structured framework is now available for the first time that clearly defines and regulatorily secures the performance and acceptance of external, so-called “third-party” audits.

VDI-EE 6306 in practice

The guideline offers:

• Standardised specifications for audit planning, performance and documentation
• Clear requirements for the qualification, independence and methodology of external auditors
• Clear regulations on confidentiality, data integrity and the legally sound 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 content of the VDI-EE 6306 – in our processes, in the selection and training of our auditors and in the preparation of standardised audit reports.

Our contribution to industry standardisation

For us, participating in the VDI-EE 6306 is not only a milestone but an expression of our aspiration to actively help shape quality assurance in the pharmaceutical supply chain. The goal was and is to establish a practical and legally sound model for third-party GMP audits – for the benefit of pharmaceutical clients, suppliers and ultimately the supervisory authorities as well.

Conclusion: third-party GMP audits with backing

With the VDI-EE 6306, companies now have a new, technically sound and regulatorily coordinated instrument at their disposal to outsource GMP supplier audits efficiently and in a structured way – without any loss of quality, but with maximum compliance certainty. Would you like to learn more about the application of the VDI-EE 6306, or are you planning to move into third-party GMP audits? Talk to us – we will accompany you from strategy to audit execution.