Quality Management

The reliable auditing of suppliers and service providers is a central obligation within the GMP compliance of pharmaceutical companies. At the same time, the complexity and scope of international supply chains are growing. As a specialised audit service provider, we take over your GMP supplier audits in a third-party procedure – legally sound, 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 ISO 9001:2015-certified – for documented traceability, continuous improvement and the highest customer focus.

Regulatorily accepted – structured auditing

The VDI Expert Opinion VDI-EE 6306 provides clear guidelines for the performance 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 sound use of audit reports by pharmaceutical clients
• Clear rules on confidentiality, data integrity and documentation

We consistently put these recommendations into practice – with processes that are ISO 9001-certified and thus externally verified, standardised and quality-assured.

Your advantages with our third-party GMP audits

• Legal certainty: Performance according to the VDI expertise and in line with the EU GMP Guide
• Quality-assured: ISO 9001-certified audit management with clear standards
• Relief: Outsourcing of supplier audits while maintaining compliance certainty
• Transparency: Fully documented audit reports for internal and regulatory use
• Cost-efficiency: Efficient audit coverage – including internationally – through experienced GxP auditors

Rely on certified quality – internally recognised, externally verified

As a qualified GMP audit service provider, we are not only technically up to date – our quality management system is certified to ISO 9001:2015. This means we meet the highest requirements for documentation, procedural certainty and audit methodology – for GDP and GMP audits that are both internally convincing and able to withstand external inspections. Whether starting-material manufacturer, packaging service provider or logistics partner – we audit your critical suppliers worldwide and provide you with robust, standardised audit reports for secure integration into your own QMS.

Benefit from an external third-party audit model that combines expertise, ISO-certified quality and VDI-compliant methodology. In this way you secure your supply chain – regulatorily clean, audit-ready and with minimal internal effort. Contact us – for GMP audits with structure, substance and system.