Audits

CARBOGEN AMCIS manufacture products according to cGMP standards and are routinely inspected by SwissMedic and the U.S. Food & Drug Administration (FDA). See below for more details on our successful audits.

GMP compliance audits

• External: FDA (AMCIS in 1997, 2002 and 2008); Swissmedic every two to three years
• External: about one per customer and year
• Internal: CarboGen and AMCIS QA, regular ongoing effort

GLP compliance audits (Aarau and Neuland sites)

• External: Swissmedic, last audit: January 2004, first audit in 2001

Change Management

CARBOGEN AMCIS effectively manages change by consistently registering all changes and deviations. Our system of change management helps us continuously improve our systems and processes to ensure the quality of our products and the safety of our processes. Within this system, we distinguish among:

• Deviations: unplanned changes, short term and depend on the situation
• Changes: planned changes
• CAPA: corrective and preventive action

Improvement Management

CARBOGEN AMCIS has implemented a strong improvement management system to continuously improve the quality of our products and our services. This system is based on:

• Evaluation of internal success factors; and
• Implementation of a well-structured process to manage corrective actions