Recognized as a world leader in the development chemistry market, quality lies at the heart of CARBOGEN AMCIS. Our state-of-the-art facilities operate to the highest standards of Good Laboratory (GLP) and Good Manufacturing Practice (cGMP).
CARBOGEN AMCIS manufactures products according to cGMP standards and are routinely inspected by SwissMedic and the U.S. Food and Drug Administration (FDA). and the French Health Agency (Agence Franšaise de SÚcuritÚ Sanitaire des Produits de SantÚ - AFSSAPS). In 2002, 2008 and 2011 we were recognized for exemplary quality of manufacturing at our Bubendorf site when the FDA conducted its latest inspections yielding no FDA 483 observations.
Quality management at CARBOGEN AMCIS encompasses the organizational structure, procedures, processes and resources, as well as the activities necessary to ensure confidence that the APIs produced will meet their intended specifications for quality and purity.
The process involves the active participation of management and appropriate personnel and ensures that all quality-related activities are defined and documented.
Our Quality Management System has been developed on the basis of the Q7A guidelines of the International Conference on Harmonisation (ICH).
Our Global Head of Quality Management oversees all sites to ensure that all quality standards are met and exceeded.
The quality units are independent of production, containing separate groups which fulfill quality assurance, quality control and regulatory responsibilities.
Quality at CARBOGEN AMCIS is integrated with aligned standard operating procedures (SOPs) and documentation systems. These systems are contractually covered by a single Global Quality Agreement for all the phases of clinical development from bench through commercial production.
Management Handbook (MHB)
The management handbooks at CARBOGEN AMCIS define and describe the management systems in place for all fields of activities. They describe the goal-and-process-oriented planning, organization and control of all working processes in view of safety, quality, time, costs and customer and employee satisfaction.
The handbook is available to all employees in an electronic form on our Intranets with links to our SOPs, guidelines, document templates and checklists.