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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 Nationale de Sécurité du Médicament et des Produits de Santé – ANSM). See below for more details on our successful audits.

GMP compliance audits
  • External:
    • FDA: Bubendorf (CH) latest in September 2014, Neuland and Aarau (CH) 2015
    • SwissMedic: every two to three years - Aarau, Neuland and Bubendorf (CH) latest in 2014, Vionnaz (CH) 2015
    • French Health Agency (ANSM): Riom (FR) 2014
    • Korean FDA: Bubendorf (CH) 2013, Neuland (CH) 2014
    • Accreditation as foreign manufacturer for Japan
  • Customer audits all over the year
  • Internal: CARBOGEN AMCIS QA, regular ongoing effort

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 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.

News
11 October 2017
CARBOGEN AMCIS Announces a Successful FDA Inspection of its Headquarters Site in Bubendorf, Switzerland

21 July 2017
CARBOGEN AMCIS Sites at Bubendorf, Aarau and Neuland in Switzerland Successfully Pass Swissmedic Inspection

11 August 2016
Dishman Celebrates a Decade of Success Since Acquisition of CARBOGEN AMCIS


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