UK to Implement Risk-Based Software for Regulatory Inspections

The UK's Medicines and Healthcare products Regulatory Agency (MHRA) has announced that it plans to implement new software designed to facilitate its risk-based approach to conducting medicines-related inspections.

"We have a defined resource and an increasing number of inspections we require to consider," explained Gerald Heddell, MHRA's Director of Inspections, Enforcement and Standards.

"This information available will ensure that our resource is utilised effectively and that less inspection time is spent on companies with a good compliance record, and therefore a lower risk," he continued, adding that the inspection software should allow the agency to better prioritize inspections and analyze the information they generate.

It will take 12-18 months to build a sufficient repository of data before the new software's potential can be realized, regulators said. The system will be run by Accenture, a global consulting firm, and run on an Oracle software platform.

The inspections carried out by the MHRA cover: Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), Good Clinical Practice (GCP), Good Distribution Practice (GDP), Good Pharmacovigilance Practice (GPvP) and Blood Safety & Quality Regulations (BSQR).