GMP Inspections: Enhanced International Collaboration

The international exchange of information between authorities is intensifying - which is certainly - against the background of increasing globalisation - a meaningful development. For example in January, the US American Health Agency FDA informed the Swiss Authority Swissmedic about renewed serious GMP deficiencies at the Indian manufacturer Ranbaxy. The Swissmedic informed in writing Swiss companies using APIs or medicinal products from Ranbaxy about the situation. Now, those companies have to prove that they've fulfilled their obligations to ensure the quality of imported APIs and/ or medicinal substances. This concretely means for them to demonstrate not only how Ranbaxy complies with the GMP requirements for the manufacture of its products, but also the quality of their finished products (made of imported substances).

In the future, collaboration between the German BfArM and the Swissmedic should also become closer. In January, they both signed a declaration of intent. The purpose of this declaration of intent is to encourage the exchange of information between them and the understanding of their respective regulatory requirements.

The European EMA is also actively involved. Indeed, it has begun to issue so-called GMP Non-Compliance Statements and entered them in the EudraGMDP database in order to make the information available for all EU Member States. These Statements contain the outcomes of GMP or GDP inspections performed by national or European authorities. Measures have already been taken from the 85 Non-Compliance Reports available: CEPs have been withdrawn (most of them concerned India and China). Moreover, the products of companies which have got a Non-Compliance Statement are no longer marketable.