NIBSC is the UK’s Official Medicines Control Laboratory (OMCL) and  European Official Control Authority batch release testing is undertaken for biotherapeutics which fall within the relevant legal framework. OMCL testing is performed to quality standard ISO 17025 and involves a range of different analytical techniques as well as detailed protocol assessment to ensure conformity with licence specifications. Products evaluated include some monoclonal antibodies, immunoglobulins (normal intramuscular and subcutaneous, specific and intravenous immunoglobulin), albumin, factor VIII, factor IX, activated pro-thrombin complex concentrate, anti-thrombin, fibrin sealants and virus inactivated fresh frozen human plasma.