Auditor Team

The team of auditors essentially consists of our own employees. To ensure comprehensive training in European and ICH guidelines and to avoid any appearance of conflicts of interest, external auditors are generally avoided. No subcontracting! The auditors are trained and certified by the European Compliance Academy and have extensive experience in local practices and standards.

We look for these qualities in auditors:

• Professional competence through education, experience, and training
• Ability to evaluate the impact of GMP deviations on product quality and safety
• Soft skills to gain support from the audited personnel

The auditors hold degrees in chemical or pharmaceutical engineering and have years of work experience in pharmaceutical plants. In addition to our internal training on European and US guidance, they are members of the European Compliance Academy and attend its training. They are certified QA Managers and/or Auditors by the European APIC.