EMEA Drafts Pilot Project for the Rationalisation of GMP Inspections

The EMEA proposes a pilot project for a comprehensive system, in which the inspection activities of the national inspectorates are meant to be co-ordinated more effectively. The proposal provides that in the beginning only a small group of interested inspectors and/or authority representatives communicate their planned inspection activities among themselves and co-ordinate them. The whole project is to be based on the system of centralised inspections already existing within the EU.

The idea is as follows: The participating inspectors / authority representatives outline their provisional inspection schedules of the 6-12 months to come and share this information with the other participants of the pilot project. Then these examine whether they:

  • have already inspected the site themselves
  • also plan to inspect the site in the same period
  • are interested in this site for another reason

For this purpose, an appropriate form is to be prepared. In case of overlaps, a telephone conference is to be organized in order to clarify the following points:

  • can one of the participants in this programme take over the inspection of another participant
  • can a joint inspection be organised
  • can an inspectorate conduct the inspection and communicate the results to the others

During the pilot phase, the activities are to remain limited to API manufacturers. For once, this phase is planned for a duration of 12 months. If this should be successful and lead to improvements, the group of participants will be enlarged and extended to other pharmaceutical companies. It is also conceivable that GCP and pharmacovigilance inspections will be integrated.

The document on the pilot project is dated December 2007, however, the contents were not published before 22 July 2008 by the EMEA. The document can be found here.

Wolfgang Schmitt
On behalf of the European Compliance Academy (ECA)

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