A milestone contribution to ensure consistent quality in GMP audits.


Blue Inspection Body GmbH participates in establishment of VDI expert recommendation for conducting 3rd-party GMP audits.
Until now there has been a lack of detailed instructions for the performance of 3rd-party GMP audits. The new guidance improves the efficacy of audits and facilitates the cooperation between pharmaceutical manufacturers and their suppliers while ensuring highest quality in this area.

For the manufacture of medicinal products in the European Union, it is stipulated that the holder of a manufacturing authorisation must only use active substances which have been manufactured in accordance with good manufacturing practice (GMP). GMP compliance shall be verified by conducting audits at the manufacturing sites of the active substances. The holders of the manufacturing authorisation can verify such compliance either themselves or through an entity acting on their behalf, such as a 3rd-party audit organisation.

In addition to saving costs, the use of 3rd-party audits has many benefits. The audits are performed by experienced and specifically trained auditors. Auditing companies with well-structured processes work in accordance with a certified or even accredited quality management system. Blue Inspection Body as a leading provider of GMP audits for over 15 years is accredited by the German accreditation body (DAkkS) for the performance of audits at API and excipient manufacturers.

According to EU GMP (part I) requirements, audits need to be of an appropriate duration and scope to ensure that a full and clear assessment of GMP is made. Audit reports should fully reflect what was done and seen on the audit with any deficiencies clearly identified. Blue Inspection Body already works to these highest standards and thanks to its extensive experience and expertise, helped identify shortfalls and gaps in the current GMP guidelines.

Aiming to close this gap, an expert recommendation related to performance of 3rd-party GMP audits has recently been developed under the umbrella of the VDI – the association of German engineers. The expert recommendation covers the complete process of auditing by third parties, including the preparation, execution, and follow-up of audits. In addition, a summary concerning the expert recommendation has been published in the journal pharmind. The expert recommendation was prepared by a panel of experts and describes the essential requirements in a precise manner. Furthermore, the extensive appendix provides a lot of practical support. A must-read for anyone involved in GMP audits!


Blue Inspection Body GmbH
Am Mittelhafen 56
48155 Muenster, Germany
Phone: +49 251 284 972 93