Summary

MHRA GMP Inspection Deficiency Data Trend 2016

Author:

Monitoring & Reporting Work Group

The MHRA has improved the way of gathering the inspection deficiency data for 2016. The new data trending can allow industries to identify:

  • The severities and frequencies by the EU GMP references
  • The overall number of deficiencies by categories: Critical, Major, Other
  • The high impact vs. high frequency issues

The purpose for publishing the inspection deficiency data is to allow industries to perform their own assessment against the deficiency findings as part of self-inspection and continuous improvement. It should be noted that the data set is for dosage forms only.

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