FINAL Part 3: The FDA and MHRA’s Most Recent Drug Inspection Observations

Continued from Part 1 and Part 2

MHRA Inspection Deficiencies

I won’t reproduce the graphics from the MHRA slide deck; do read those because they contain a wealth of information at a granular level.

  • Figure 3A shows the distribution of deficiencies among the 3 classifications by actual number for 2015 and 2016.
  • Figure 3B shows this distribution of deficiencies among the 3 classifications by percentage for 2015 and 2016.
    • The percentage of the deficiencies in each classification are almost identical for the 2 years, though the absolute number of each differ markedly.
  • Table 3 and Figure 4 present the number of critical deficiencies and the associated Chapter/Annex for 2016.
  • One difference between the 2 years is that MHRA identified critical deficiencies in 5 Chapters/Annexes in 2015 and this increased to 10 Chapters and Annexes in 2016.
  • In 2016, the MHRA inspectors identified almost 3 times more critical deficiencies in double the number of GMP areas than in 2015.

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  • Among the 10 Chapters and Annexes identified with critical deficiencies in both years, the number increased in 8 Chapters and Annexes and decreased in 2.
    • Those with decreases were Documentation, Chapter 4, which decreased from 9 in 2015 to 2 in 2016 and Quality Control, Chapter 6, which decreased from 4 in 2015 to 2 in 2016.
  • The numbers remained essentially the same for Chapter 8, Complaints and Recalls, at 10 and 11 respectively for 2015 and 2016.
  • Among the most areas with marked increases were 6 Chapters and Annexes against which MHRA did not identify critical deficiencies in 2015.  
    • In 2016, these numbers ranged from 8 to 34 critical deficiencies.
    • The 2 largest increases were in Sterility Assurance, Annex 1 which increased from 0 to 34 and Production, Chapter 5 which increased from 0 to 20.
    • Quality Systems, Chapter 1 increased from 27 to 38 in 2016.
  • Consistent with the ongoing focus on data governance, particularly for electronic records, the critical deficiencies identified citing Computer Systems, Annex 11 increased from 1 to 9 between the 2 years.
  • Critical deficiencies for Chapter 2, Personnel increased from 0 in 2015 to 8 in 2016.



Table 3:  Number of Critical Observations in Various Areas


It is difficult to directly compare MHRA areas with critical deficiencies against inspection observations identified by FDA. FDA does not categorize the criticality of inspection observations.

For those who use inspection observations to monitor and improve their quality systems, both publications provide ample resources so firms can measure their potential vulnerabilities and gauge their focus areas for both health authorities during GMP inspections.

Both stress the importance of an effective Quality System. While the MHRA identifies this separately, the FDA’s focus on investigations/procedures have consistently scored high on the list of inspection observations. In both presentations and publications, both health authorities focus on the importance of an effective Quality System.

Both health authorities show changes in their focus compared to the previous year, perhaps most striking for the MHRA which nearly tripled the number of critical deficiencies and expanded the areas where they identified deficiencies from 5 Chapters and Annexes to 10 Chapters and Annexes. The MHRA’s focus on identification of critical deficiencies in sterility assurance is similar to FDA’s focus on this area as a high-risk drug production category.

We have multiple years of data for FDA; it will be interesting in the next few years as we accumulate more data for MHRA and are able to evaluate trends over a longer time period.  

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About the Author

Barbara W. Unger is Govzilla’s Quality Expert and Editor-in-Chief of GMP Regulatory Intelligence.  She formed Unger Consulting, Inc. in December 2014 to provide GMP Quality consulting services to the pharmaceutical and biopharmaceutical industry.  At Amgen, she led the segment of the Corporate GMP Audit group at Amgen focused on API manufacturers, Quality Systems and Computers.  She developed, implemented and maintained the GMP Regulatory Intelligence program for 8 years at Amgen Inc.  This included surveillance, analysis and communication of GMP related legislation, regulations, guidance and industry compliance enforcement trends.  This was an essential service and tool within the Corporate Audit function.

Unger Consulting Inc. | | 805.217.9360

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