Quality management
ISO 9001-Certified Third-Party GMP Audits According to VDI Expert Opinion (VDI-EE 6306)
Reliable auditing of suppliers and service providers is a key obligation for pharmaceutical companies in ensuring GMP compliance. At the same time, the complexity and scope of international supply chains continue to grow. As a specialized audit service provider, we conduct your GMP supplier audits using a third-party approach – legally compliant, efficient, and based on the VDI Expert Opinion “3rd-Party GMP Audits – Supplier Audits in the Pharmaceutical Industry” (VDI-EE 6306).
Our quality promise: Our audit processes are certified according to ISO 9001:2015 – ensuring documented traceability, continuous improvement, and maximum customer focus.
Regulatory Acceptance – Structured Auditing
The VDI Expert Opinion VDI-EE 6306 provides clear guidance for the execution and acceptance of third-party GMP audits:
- Transparent audit planning and risk assessment
- Clear definition of responsibilities
- Requirements for the qualification, independence, and methodology of external auditors
- Legally compliant use of audit reports by pharmaceutical clients
- Clear rules on confidentiality, data integrity, and documentation
We consistently implement these recommendations in practice – with processes that are ISO 9001-certified and thus externally verified, standardized, and quality-assured.
Your Benefits with Our Third-Party GMP Audits:
- Legal Compliance: Execution based on VDI guidance and aligned with the EU-GMP guidelines
- Quality Assurance: ISO 9001-certified audit management with defined standards
- Relief for Your Team:Outsourcing supplier audits while maintaining compliance security
- Transparency: Fully documented audit reports for internal and regulatory use
- Cost Efficiency: Effective audit coverage – even internationally – by experienced GxP auditors
As a qualified GMP audit service provider, we are not only technically up to date – our quality management system is certified according to ISO 9001:2015. This means we meet the highest standards for documentation, procedural reliability, and audit methodology – for GDP and GMP audits that meet internal expectations and withstand external inspections.
Whether it’s an API manufacturer, packaging service provider, or logistics partner – we audit your critical suppliers worldwide and deliver reliable, standardized audit reports for seamless integration into your own QMS.
Benefit from an external third-party audit model that combines expertise, ISO-certified quality, and VDI-compliant methodology. This way, you secure your supply chain – regulatory-compliant, audit-ready, and with minimal internal effort.
Contact us – for GMP audits with structure, substance, and system.
