Compliance
Audits
CARBOGEN AMCIS manufactures products according to cGMP standards and are routinely inspected by SwissMedic and the US Food & Drug Administration (FDA) and the French Health Agency (Agence Française de Sécurité Sanitaire des Produits de Santé - AFSSAPS). See below for more details on our successful audits.
GMP compliance audits
- External: FDA (AMCIS in 1997, 2002, 2008 and 2011); SwissMedic every two to three years, French Health Agency (AFSSAPS) in 2009 (Riom, France site)
Customer audits all over the year - Internal: CARBOGEN AMCIS QA, regular ongoing effort
GLP compliance audits (Aarau and Neuland sites)
- External: SwissMedic, last audit: November 2006, 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 depending 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
Japan
CARBOGEN AMCIS has recently obtained the accreditation as foreign manufacturer for Japan.
Third-Party Auditing
The nature of the project or our clients’ development strategy frequently requires
that we coordinate work with other third parties, such as raw material suppliers or
analytical chemistry laboratories. In this case, we provide auditing services to
offer a clear picture of the quality level of all parties involved in the project.
