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2015 GMP inspection deficiency data trend

Posted by: , Posted on: - Categories: Compliance matters, Good manufacturing practice

The 2015 GMP  inspection deficiency data trend has been published yesterday

The GMDP Inspectorate has improved the way of gathering the inspection deficiency data for 2015. The new data trending can allow stakeholders to identify:

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

The purpose of publishing the inspection deficiency data is to allow stakeholders to perform their own assessment against the deficiency findings as part of self-inspection and continuous improvement.

Deficiency examples are included for each relevant chapter and annex for information.

Note: This is the data set for dosage form only.

Front page of the MHRA GMP Inspection Deficiency Data Trend 2015

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Access our guidance on good practice for information on the inspection process and staying compliant.

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  1. Comment by Thomas Nimmer posted on

    Dear Mark,

    Thank you for this insightful document. I work in Knowledge Management at Novartis, and would like to know if I could get a copy of spreadsheet you used to put together the bar graphs. Specifically, I've developed a process to normalize all Novartis audit/inspectional findings and compare them to FY2015/FY2016 FDA drug findings, and would like to do the same with the MHRA data. Before squinting hard at the charts and hand-transcribing the data, I was hoping you might be able to share the spreadsheet with me.
    Very best regards,

    Thomas Nimmer
    QRM, Knowledge Mgmt Director
    Novartis Services Inc.
    Group QA, GCA
    One Health Plaza, 1SR-3332A
    East Hanover, NJ 07936-1080

    • Replies to Thomas Nimmer>

      Comment by Mark Birse posted on


      The inspection metrics form a wider part of our approach to compliance management and seeking sector wide improvement. This also includes work through our Compliance Management Team (which will be the subject of a blog post later this week) and this MHRA Inspectorate blog to highlight our thinking on various topics.

      A key part of this work is exactly what you have asked for. Our future approach is to publish the raw data that we have so that it can be sliced and diced by companies, based on their own requirements and internal quality metric monitoring. Hopefully, this will allow wider sector benchmarking and assist with trending.

      Within the next couple of months we will be publishing our 2016 data and this will include a searchable spreadsheet as well as a summary presentation.

      Therefore, if you can bear with us for another month or so we will have the latest metrics and a searchable spreadsheet.

      Thank you for interest in this work.


  2. Comment by Rupinder Dhillon posted on

    Dear Mark,

    We look forward to the year on year comparisons in your 2016 data publishing. It will be very beneficial to understand the progress being made towards maintaining GMP compliance (last 5 years if possible) on average across all audit criteria's and this will also highlight areas where manufacturers need to focus on more.
    For a pharmaceutical consultant like myself, it would enable me and other stakeholders to understand the areas in urgent need of improvement and address how the wider industry can support manufacturers in these areas (best practice, technology for systems and controls, training/consultancy to aid manufacturer compliance and setting up routine procedures to adhere to as should be the norm).

    Best Regards,
    Rupinder Dhillon - Consultant
    RSD Pharmahealth Associates Limited