Quality assurance

Our quality system related to the production and control of our products is based on EU-GMP guidelines and equivalent guidelines adopted by the USA Food and Drug Administration. Quality is also weighted in our personell training system, which includes on the job training and certifications in GMP.  
 
The release of an active pharmaceutical ingredient and finished pharmaceuticals require by law qualified persons (QP), who are authorised by the Norwegian Medicines Agency. To date, there have been no product recalls of the branded products.
 
Key elements of our quality assurance system include:
•    Approval of suppliers and contract acceptors
•    Validation of equipment, processes and methods
•    Product release by qualified persons
•    Deviation handling system
•    Change control system
•    Complaints and recall system
•    Product quality review
•    Audit programmes
•    Pharmacovigilance system