The CBF is a GMP (Good Manufacturing Practice) certified manufacturing facility licenced by MHRA (Medicines & Healthcare products Regulatory Agency). Quality Assurance process starts at the very beginning of each project by incorporating quality by design throughout the supply chain from raw materials to final product.
The CBF manufactures high quality lnvestigational Medicinal Products for early phase clinical trials. We provide the link between academic research and rapid clinical drug development, ensuring patient and volunteer safety at every step of the process.
The Quality Management System (QMS) at the CBF is used to maintain compliance with UK and European regulatory requirements and GMP, in accordance with MIA (Manufacturing / Importers Authorisation), IMP ( Investigational Medicinal Product) 21584. The CBF Qualified Persons (QPs) and Head of Quality jointly have the authority and responsibility to ensure that the quality systems are implemented and maintained. This includes the review and approval of all formal documents relating to product manufacture, to plan and implement internal audits, to approve or reject raw materials and products and to carry out any other actions necessary to ensure compliance with the applicable standards. The Head of Quality and QP are responsible for setting Quality objectives and for continual improvement. See below for core quality assurance processes.
The Quality Assurance department ensures all relevant staff are trained to the appropriate GMP standard with documentation to prove that training has occurred. Yearly GMP training is provided to all staff and any significant updates to Statutory Instruments, Annexes and Guidance Notes as published by EMEA/MHRA are disseminated to the staff to ensure that all work is carried out to the highest standard.