GCP Inspection Findings published

Recommendation

15/16 September 2020

Live Online Conference: ICH Q12 Product Life Cycle Management

The U.K. Medicines and Healthcare Products Regulatory Agency MHRA has compiled a GCP Inspections Metrics Report. This report summarises 125 GCP Inspections which were undertaken by the MHRA GCP Inspectorate from 1st April 2013 to 31st March 2014. Now, almost two years later, this interesting overview was published.

When looking at the data, the importance of a robust Quality Management System becomes obvious. Observations in this area are number one for CRO Inspections and number two for Non-Commercial Sponsors closely behind Clinical Trial Oversight.  All findings are listed as major grading.