You may have come across the following statements in the MHRA GCP Inspection Metrics reports as part of the observations surrounding critical findings:

  • ‘…There was no process in place to ensure…,’
  • ‘…were not defined in the SOP nor was there any clear policy and process to ensure…,’
  • ‘There was no reference within the QMS to ensuring…;’

as well as the following from the EMA Annual reports:

  • ‘SOPs not updated as required;’
  • ‘Sponsor failure to implement an efficient quality management system.’

About 9% of all critical findings as per the EMA report published in 2020 were on Standard Operating Procedures

For more information on how Tower Mains can help you reduce the risk of finding these statements in your Inspection report, click here or email us at