Quality functions
Most of our projects involve either manufacturing of advanced stage intermediates or Active Pharmaceutical Ingredients (APIs) for pre-clinical and/or clinical trials, produced in accordance with cGMP.
NCK is committed to operating in compliance with GMP as defined by the ICH Q7 GMP Guide for APIs, and rules Governing Medicinal Products in the European Union, Vol. 4, Part II, concerning APIs for use in clinical trials.
GMP system
Appropriately staffed Quality Assurance and Quality Control functions are important parts of our GMP system. Our Quality Assurance activities comprise our internal SOP system, e.g. training of personnel, controlled production documentation and release/approval decisions and investigations. Our system is constantly being updated, through client audits, for example. More than 80 external QA groups from the pharma and biotech industries have audited our QA system over the past 25 years.
NCK holds a GMP Certificate issued by the Danish Medicines Agency.
