GMP Inspections: Enhanced International Collaboration - 09 Feb 2014
The impact of globalisation is evident in the increasing exchange of information between international regulatory agencies. For instance, the US FDA informed SwissMedic about the renewed GMP deficiencies observed in an Indian manufacturer, Ranbaxy.
The implication for Swiss manufacturing companies is that they have to demonstrate due diligence and fulfil their obligations towards GMP requirements with respect to the quality of APIs and/or medicinal substances imported from Ranbaxy. In other words, all such importers will also need to demonstrate how Ranbaxy complies with GMP requirements including quality of their finished products (made with imported substances).
Furthermore, the German Regulatory Agency, BfArM and SwissMedic took a step towards closer collaboration by signing a declaration of intent. They recently signed a declaration of intent with the objective of encouraging the exchange of information between both Agencies.
The European Medicines Agency is also actively involved in forging closer collaboration between Agencies. It has begun to issue the so-called GMP non-compliance statements and entered into the EudraGMP database so 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 Measures have already been taken from the 85 Non-Compliance Reports available: CEPs have been withdrawn (most of them concerned India and China). The products of companies with these Non-Compliance Statement do no longer have their marketing authorisation.