Course Description

Auditing of API manufacturers is receiving increasing scrutiny from European regulators primarily as a result of recent issues around counterfeiting of medicines such as the well-known Heparin scandal. In the European Union the responsibility for GMP conformity for the medicinal product lies with the Qualified Person of the holder of the marketing authorisation, and this includes GMP at the site of API manufacture.  From January 2013 the situation has become even more onerous for the MAA holder as the Qualified Person has to declare that they are satisfied with GMP controls within the whole of the supply chain, which includes the supply chain of the API manufacturer(s) used by that MAA holder.  European Union inspection bodies are placing even more scrutiny on the audits carried out for your companies to allow this declaration around the supply chain.

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