The criteria used to approve manufacturers is set out in the “guide to good manufacturing practices” and is monitored via inspection processes performed by the Medicines Healthcare Regulatory Authority (MHRA). If a company has met these standards, an “authorize to manufacture” is granted. If upon routine re-inspections, the manufacturing processes do not meet the acceptable standard, further actions are taken, as with the case of Calea UK Ltd.
NHS England and NHS Improvement’s Commercial Medicines Unit (CMU) is responsible for awarding framework agreements for England, in line with procurement regulations, for parenteral nutrition. All suppliers including Calea UK Ltd are required to provide available production capacity, satisfy quality, safety, finance and governance requirements and evidence that they hold a licence with the MHRA and meet its regulatory requirements.