The API Compliance Institute recently performed Third Party GMP Audits at two API manufacturing sites in Germany. The Audits were 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 Audits were performed by 2 certified APIC Auditors during 2 days at each manufacturing site. They were conducted according to the rules of the APIC Audit Programme. This GMP Audit Scheme is an internationally recognized auditing programme which was established 10 years ago. It is the idea of the programme to share compliance information between companies.
The following sites were audited:
Site: Excella GmbH
Nürnberger Str. 12
Site: Boehringer Ingelheim Pharma GmbH & Co. KG
Binger Str. 173
The API Compliance Institute is responsible for the controlled distribution of the audit report in which the GMP compliance situation at the two API manufacturing sites has been described in detail. More information can be obtained from the following source: Press Release API Compliance Insitute