EMEA Publishes Content of the GMP Inspections Database for the First Time

GMP News No. 891: EMEA Publishes Content of the GMP Inspections Database for the First Time

GMP News
21 February 2007

EMEA Publishes Content of the
GMP Inspections Database for the First Time

For the first time, the European Medicines Agency EMEA has published an analysis of regulatory inspection findings in the centralised procedure. The report on inspection deficiencies comprises GMP inspections carried out by EEA competent authorities on behalf of the EMEA during the period 1995-2005. A total of 9465 deficiencies, including 193 critical (2%), 989 major (10%) and 8283 other deficiencies (88%) were recorded in the EMEA database during the 435 inspections.p>

The ranking of total GMP deficiencies found in the years from 1995-2005 reveals that 14.1% of all incidents relate to "Documentation – quality system elements/procedures" – making documentation the top subject on the list with a significant gap. In addition, other deficiencies related to documentation also made it to the top ten list of this observation analysis.

If all top 10 deficiencies related to documentation issues were combined, they would make up for more than 24% of all deficiencies. That means almost one out of four observations corresponds to a problem with documentation. This is a considerably high amount and underlines the importance of high quality GMP-compliant documentation in the pharmaceutical industry.

Other most frequently registered deficiencies in this period were design and maintenance of premises and design and maintenance of equipment – with 6.7% and 6.2% respectively directly following documentation.

When comparing the seriousness of GMP violations, the records show violations relative to design and maintenance of premises on top of the list of critical deficiencies, followed by potential for microbiological and chemical/physical contamination.

The data from the report can be used as orientation for future audits or for advanced inspector trainings in these areas. They can also help to draw conclusions on what areas will need to be more emphasized in a revision of the EC GMP Guidelines.

No. Category of GMP deficiency Number Incidence
1 Documentation - quality system elements/ procedures 1341 14.1
2 Design and maintenance of premises 634 6.7
3 Design and maintenance of equipment 594 6.2
4 Documentation - manufacturing 526 5.5
5 Contamination, microbiological - potential for 463 4.9
6 Documentation - specification and testing 432 4.5
7 Status labelling - work in progress, facilities and equipment 371 3.9
8 Environmental monitoring 323 3.4
9 Process validation 317 3.3
10 Sampling - procedures and facilities 297 3.1

Top 10 ranking of total GMP deficiencies for 1995-2005

By the way: The ECA has recently published the FDA Warning Letter Report (see our News from 10 January 2007) and an overview about findings of the MHRA (see our News from 03. October 2006).


Learn more about the regulatory requirements and how to run your documentation and quality systems efficiently and in compliance with GMP regulations – in the following ECA courses:

from 26 – 27 June 2007 in Warsaw, Poland
  • GMP and FDA compliant Quality and Documentation Systems

  • from 22 – 23 October 2007 in Copenhagen, Denmark

    Also, the GMP/FDA compliant design, regulatory requirements, qualification/validation as well as documentation are part of the 4-day course

    from 8-11 May 2007 in Prague, Czech Republic

    Wolfgang Schmitt & Dr Robert Eicher
    On behalf of the European Compliance Academy (ECA)
    Source: EMEA Report on Inspection Deficiencies

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