Our facilities within CTP working under GLP regulations have established quality system, which is regularly inspected internally by Quality assurance unit and by National Authority and by our customers.
Quality of our services is top priority for all our team members
Non-clinical studies performed on our facilities are accomplished in compliance with OECD GLP regulations. We focus on compliance with GLP right in the beginning of study preparation. Study plan, study execution and final study report are evaluated not only concerning correctness of acquired data, but also in terms of compliance with GLP as defined in OECD GLP guideline OECD SERIES ON PRINCIPLES OF GOOD LABORATORY PRACTICE AND COMPLIANCE MONITORING. Each and every study is subject to at least 3 quality inspections in defined critical points. Test facility and relevant test sites are subject to regular inspections twice a year, covering premises, equipment and processes.
Studies performed in our test facility under GLP are fully recognized for regulatory purposes of drug products.
Al animals used in our test facility and test sites are purchased from accredited breeding facilities. We act according to 3R principles (Replacement, Reduction and Refinement) to reduce both the necessary amount of animals within the study, as well as to reduce suffering and stress of animals due to proper study design and consider carefully their welfare. Laboratory animals are used exclusively for the studies of potentially lifesaving therapeutics and where possible alternative methods are used.