Rammell Consulting Limited

MHRA Publishes Latest GCP Inspection Findings


The MHRA today released on their website their annual report of GCP inspection findings. It is interesting to note two critical findings for data integrity issues…. something that industry has been talking much about over recent months. It would be wise to do a comprehensive review of the MHRA draft guidance on this topic!

In addition, the MHRA cited a critical finding for management and maintenance of the trial master file (TMF). This includes the following:

Many of these observation reflect what is now becoming our common industry understanding of the MHRA expectations for a TMF…. so shouldn’t be a surprise anymore. However, it may be worth passing comment on a couple of these topics:

Go to the MHRA website to view the full report.