Insights from 11 Years of Good Clinical Practice (GCP) Inspections

Although only 20% of all GCP inspections are conducted at sponsor sites, the majority of critical observations are identified there. In this analysis, 11 years of GCP inspections conducted by the GCP Inspector Working Group (GCP-IWG) from 2013 to 2023 were reviewed. The findings indicates that, from a sponsor’s trial management perspective, developing and implementing a robust data management and a monitoring plan can reduce the likelihood of receiving a critical deficiency by 60%.

Medicines entering the European Union through the centralized procedure are reviewed and authorized by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP). As part of the approval process, the CHMP may request the GCP-IWG to conduct an inspection to determine whether a clinical trial is, or has been, conducted in accordance with local regulations and GCP principles.

For a sponsor, investigator, or clinical research organisation (CRO), receiving notice of an impending inspection can understandably induce stress and concern.

Each year, the GCP-IWG conducts inspections both within Europe and internationally. Approximately 60% of these inspections take place at clinical investigator sites, 20% at sponsor sites, and 8% at CRO sites. The remainder are conducted at analytical laboratories and other facilities. Upon completion of an inspection, the GCP-IWG issues a report detailing any deficiencies identified and provides an overall compliance rating for the site.
These reports are available online and can be leveraged to better prepare the site for an inspection.

Table 1 summarizes the total number of inspections conducted each year alongside the total number of deficiencies reported. While the number of inspections fluctuated over the 11-year period - largely due to the impact of the COVID-19 pandemic - the number of deficiencies per inspection remained surprisingly consistent. The coefficient of variation was only 9.2% with most years showing between 10 and 13 deficiencies per inspection, indicating a stable pattern in inspection outcomes despite variability in inspection volume. This pattern is reminiscent of an anecdote shared by a quality manager following one of his inspections. After completing the review, the inspector approached the quality manager and said, “Your site has passed the inspection, but in the spirit of continuous improvement, I have to find something you can improve.” The consistency in deficiencies per inspection observed in this analysis seems to echo that sentiment, there’s almost always something to be found.