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Wednesday, October 26, 2016

Attention All: Annual report of the Good Manufacturing and Distribution Practice Inspectors Working Group 2015


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EMA's GMP/GDP Inspectors Working Group has published its annual report. This group of senior GMP Inspectors meets on a regular basis four times a year. The group consists of representatives of the GMP inspectorates of the European Economic Area Member States, a representative from the European Commission (DG Enterprise and Industry) and observers from EDQM, the inspectorates of the countries accessing to the EU and MRA partner countries. The Sector provides the chair and secretarial support for these meetings.
The meetings consider new and revised GMP related guidance, normally developed by drafting groups, work related to Mutual Recognition Agreements, how new legislation impacts GMP inspection activity and harmonisation of GMP inspections. The outcome of the work is summarised in annual reports. The reports also briefly summarise number and outcome of GMP inspections in third countries and the status of the current Mutual Recognition Agreements (MRAs) and other agreements on GMP.

      A breakdown of the figures corresponding to those third countries where EEA authorities conducted the highest number of GMP inspections in 2015 is given below. They have been split according to their outcome (i.e. GMP certificates vs. non-compliance statements).

2015
Country             GMP certificates            GMP Non-compliance statements
India                            135                                           6
United States               110                                          1         
China                            72                                            6         
Turkey                          18                                            0
Japan                            13                                           0
Taiwan                          09                                           0
ROW*                           79                                           0


Download full report: Please see the Annual report of the Good Manufacturing and Distribution Practice Inspectors Working Group 2015 for more detailed information.

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