FDA, EMA and TGA Inspection Programme with impressing Result

The international pilot programme for conducting GMP inspections at API manufacturers is an impressive success. The pilot programme's provisional results were summarised in the interim report on 23 September.

The programme started in December 2008 and was initially planned for 18 months only. It was then extended for another six months, though. Its goals are:

  • Avoiding duplicate inspections of the same API manufacturer
  • Taking advantage of the gained resources for inspections of other API manufacturers (especially in Asia) and thus increasing the overall number of inspected API manufacturers

Until today the involved authorities transferred a total of 1.046 API manufacturers to the common inspection database (Master List). The FDA transferred 352 of them, the Australian TGA communicated 195 API manufacturers. Not all European countries participated in the programme. Still, Europe communicated 499 API manufacturers: France (44), Ireland (4), Italy (11), UK (51) and Germany transferred 104 sites. The European authority EMA (previously EMEA) added 112 sites, the European Directorate for the Quality of Medicines and Healthcare (EDQM) another 173.

In total 532 API manufacturers were identified in the list that at least two authorities planned to inspect. From those 90 manufacturers were even interesting for all three regions - Europe, the US and Australia.

To avoid overlaps, there were several joint inspections already. For instance, Europe (EMA, EDQM) participated in six joint inspections (five of which with TGA and one with FDA). There were still a number of duplicate inspections where an API manufacturer was inspected from two authorities of the pilot programme within the same year. This concerned a manufacturer in Japan, two in China and seven in India.

The database (Master List) additionally comprises information on conducted inspections. That way it is possible that the participating authorities can request the inspection report to either cancel their own inspection, to postpone it or to use the received information to conduct their own inspection more target-oriented. The FDA, for example, requested a total of 20 inspection reports from European authorities, and the European authorities requested 47 from the FDA.

Due to the impressive results it can expected that the programme will be extended in December 2010. However, there was no decision made yet. Another interesting information is coming from the numbers: even though the authorities did not transfer all API manufacturers into the Master List and even though not all EU countries did participate, it can be deduced that the total number of API manufacturer supplying the European market is a lot smaller than frequently reported. In the past it was often mentioned that the number of API manufacturers that are supposed to be inspected as part of the obligatory GMP supervision is so high, that a comprehensive supervision would nearly be impossible. The numbers were ranging from several 1.000 to 20.000 API manufacturers supposed to be inspected. A more realistic number is clearly under 1.000 companies, though. In combination with the pilot programme a comprehensive GMP supervision can therefore be seen as a manageable exercise.

Oliver Schmidt
On behalf of the European Compliance Academy (ECA)

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