Currently, the FDA is making comprehensive changes to its foreign inspections, i.e. inspections conducted outside the USA. The measures have among others been selected due to the so-called Heparin Case, which caused about 100 deaths within the USA. During the ensuing investigations, it has become clear that the FDA has to revise its current inspection system. Now, individual measures are taking shape.
The initiative to open offices in China, especially in order to be able to better supervise the manufacturers of active pharmaceutical ingredients there, met with general approval. Last but not least a number of major GMP deficiencies were revealed in China. In the past, deaths in Asia and Africa hardly attracted attention; but now the problem is not restricted to a geographically defined region any longer. Today, the core of the problem consists in the USA's and Europe's dependency on active ingredients from China and India. Whereas during the 1980's, the major part of active pharmaceutical ingredients was still manufactured in Europe and the USA, today it is assumed that up to 80% of the active ingredients come above all from China and India. What experts had suspected for many years now seems to become apparent: Many active pharmaceutical ingredients manufacturers in China and India are not GMP compliant and are furthermore a starting point for counterfeits. In the Heparin Case, too, not only were almost incredible GMP deviations found at the premises of the Chinese active ingredient manufacturer, the active pharmaceutical ingredient itself was also thinned down by means of a cheaper substitute. The 483 form regarding the inspection as well as the warning letter have been published on the Internet by the FDA. The firm has been shut down in the meantime.
Now the FDA has sent 8 experienced inspectors to China. In order to be able to take action as comprehensively as possible, the FDA will train Chinese representatives. Offices have been opened up in Beijing, Guangzhou and Shanghai. A corresponding press release by the US government was published on 18 November 2008. Further sites will be added. There are e.g. considerations to open offices in India, but maybe also in Europe.
With the new government under President Obama, it is also considered probable that the FDA will carry out a far larger number of inspections in all regions outside the USA. While according to an analysis by GAO (September 2008) every manufacturer of medicinal products or active pharmaceutical ingredients in the USA was subject to a GMP inspection on average every 2.7 years, outside the USA the average frequency is just every 13 years. These results have drawn much attention of the political decision-makers to this subject. A draft version of the so-called FDA Globalisation Act has been presented to the deciding bodies. This act would bring about a fundamental change for the FDA and the supervised industry outside the USA. Apart from a several times higher number of inspections, the act proposes to indicate the origin of the active pharmaceutical ingredients on the packaging of the medicinal product. The decision to procure active ingredients from China and Asia for financial reasons can prove to be a fatal mistake if the FDA inspections confirm the suspicion that many companies do not work in compliance with the GMP rules. Apart from the consequences for the already marketed batches, the search for an alternative manufacturer will become difficult. Today, many active pharmaceutical ingredients are not produced in Europe or the USA any longer.
On behalf of the European Compliance Academy (ECA)