The GMDP Inspectorate has recently implemented a non-statutory process to take action in response to poor compliance which does not yet meet the threshold for consideration of adverse regulatory action. The Compliance Escalation process forms an extension of the existing RBI process, prior to consideration of regulatory action. The main aim of the process is to direct company towards a state of compliance, thus avoiding the need for regulatory action and the potential adverse impact to patient health through lack of availability of medicines as a result of action against an authorisation, as well as avoiding reputational and commercial damage for the manufacturer and product owner. Additional information is available in our Compliance Escalation section.
Good Manufacturing Practice: Compliance escalation process