MHRA to use statistical monitoring to target risk-based inspections

The UK Medicines and Healthcare products Regulatory Agency (MHRA) is extending its software systems to inform risk-based targetting of future inspections.

The system stores all information from previous inspections and, using a statistical algorithm, compares data against previous and/or current company issues to help inform the inspection planning and process.

The system will help to target inspections to the areas of greatest risk, ultimately helping to protect public health, while also reducing the overall administrative and economic burden on organisations who demonstrate a high level of compliance. The full potential of this software will not be seen for 12-18 months, when a sufficient repository of data has been built up.

Gerald Heddell, the MHRA’s Director of Inspections, Enforcement and Standards, said: “Our inspectorate teams will focus their time on inspections in order of priority from the risk signals flagged. We have a defined resource and an increasing number of inspections to consider. This information 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.”

The system was developed and implemented in collaboration with Oracle Health Sciences and Accenture.