The company Axenic wants to launch its new product Vanic. In order to do so various tests of the product have to be performed, also via HPLC. Since the company Axenic doesn’t own such a unit due to capacity reasons, an external, also GMP-certified company which owns
an HPLC-testing-laboratory is being employed.
Before any studies are performed in the HPLC-testing-laboratory, the company will be audited by Axenic. Presented in this paper are the audit-plan and audit-report of the conducted audit including related documents.