Another Third Party GMP Audit performed in Germany by API Compliance Institute

The API Compliance Institute has performed a Third Party GMP Audit at

Excella GmbH
Nürnberger Str. 12
D-90537 Feucht
Germany

The Audit was initiated by a group of Qualified Persons and QA Managers from different pharmaceutical companies who are using the respective APIs to manufacture their medicinal products. The initiators as well as the Auditee agreed to share the audit reports with other companies.

The GMP Audit was performed by a certified APIC Auditor during 3 days at the manufacturing site. It was conducted according to the rules of the APIC Audit Programme. This GMP Audit Scheme is an internationally recognized auditing programme which was developed by APIC/CEFIC in line with the European Authorities guidances. It is the idea of the programme to share compliance information between companies.

The API Compliance Institute is responsible for the controlled distribution of the audit report in which the GMP compliance situation at the API manufacturing sites has been described in detail. For more information about the APIC Audit Programme and the API Compliance Institute please contact Dr. Gerhard Becker becker@api-compliance.org