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Quality Management

CDMO Quality services | Quality Management

Committed to the safety of patients through commitment to quality

CARBOGEN AMCIS has quality running through it and everything we do has a fundamental basis in ensuring patient safety through a phase appropriate approach. Quality is central at CARBOGEN AMCIS as this is crucial to the success of a project.

Our state-of-the-art API and drug product facilities operate to the highest standards of current Good Manufacturing Practice (cGMP), our Manchester UK facility operates to a fully-embedded quality standard, designed to ensure the consistent quality of starting materials and industrial products. Our facilities are routinely inspected by national and international regulatory authorities and, of course, by our customers. Our long and successful audit history proves our high quality standards.

Our fully integrated quality team (quality assurance and quality systems) conducts regular internal audits of each department within the company so we can maintain and continue to implement the philosophy of producing the highest quality standards. We also conduct external audits of our suppliers with the support of our quality control and analytics team as well as our regulatory affairs department to guarantee the reliability of our partners.

The fundamental role we play in keeping a high quality level in our systems in order to deliver quality APIs to our customers in a timely manner is what interests me the most about my role.

Stéphanie - Senior Manager Corporate Quality, Bubendorf

More than
of employees work in the Quality Department
are PhD Chemists within Quality Assurance
More than
customer audits
each year

Quality Fundamentals

  • Based on the ICH-Q7 Guideline
  • Fully compliant with:
    • ICH Q8, 9, 10 & 11
    • All ICH guidelines, as applicable
  • All quality processes described in Management Hand Book
  • Structure of management handbook in accordance with ISO 9001:2000
  • Compliant to Swiss, EU and FDA Guidelines
  • State-of-the art ADE based cleaning validation concept fulfilling current EMA guideline

Product Quality Assured

  • QbD (Quality by Design) approach
  • Classical and Lifecycle validation approach according to FDA guidelines
    • PAR studies
    • Process optimization by statistical DoE (Design of Experiment) as required
  • Product quality risk assessment

For more information
download our Company
Profile brochure