Final Report on the International API Inspection Programme published

An international inspection pilot programme on API manufacturers was started in December 2008. Following countries and their competent authorities were involved in the project: France (AFSSAPS), Germany (ZLG), Ireland (IMB), Italy (AIFA), United Kingdom (MHRA), EDQM, FDA (USA) and Australia (TGA). This pilot programme aimed at enhancing general exchange of information regarding reports about performed inspections and planning dates for the inspections to come in order to avoid unnecessary double inspections. A so-called "Master List" was used. The participants of the programme had to indicate the name of the API manufacturers, the date of the last performed inspection, the result of it and the dates planned for further inspections. This updated Master List was sent regularly by the EMA at least once a month to each participant.

On 2 August, the EMA published the final report on this API inspection programme together with a report on inspection of clinical trials/ testing facilities performed during the same time. At the finalisation stage of the report, 1110 entries were recorded in the Master List which corresponded to inspections conducted between 2005 and 2008 as well as to sites planned to be inspected. The report lists the number of inspections ordered by uthorities - performed in countries with inspection date. This increased transparency about API sites monitored by 2 or more participants. For example, 97 sites are monitored by all the participants. Thanks to this visibility, the number of unnecessary double inspections could be decreased. Instead, joint inspections were planned and performed.

The authors of the report observed that the programme definitely brought more transparency and efficiency for the planning and realisation of authority inspections. Following propositions have been mentioned for the continuity of the programme: the possibility to identify "critical" API sites for example in terms of monopoly position for the manufacture of an API as well as the development of common principles related to the re-inspection of sites (based on risk)

It is explicitly mentioned that the collaboration between the participating national authorities should continue and that the objective is to extend the programme to all the EU Member States.

For more details please see the EMA press release on the pilot programme report as well as

the final report.

Dr Gerhard Becker
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)

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