Danish Medicines Agency launches Project on Monitoring of GMP Compliance of APIs

On March 12, 2009 the Danish Medicines Agency (DMA) published the following information (the text is taken from DMA's webpage with minor changes only):

The DMA has launched a project focusing on compliance with the rules by manufacturers of active pharmaceutical ingredients in 2009. In connection with the project, the DMA will spot check whether the rules are followed in connection with the manufacture and handling of API. The inspections and laboratory analyses carried out in connection with the project are considered as part of DMA's normal control and monitoring.

The 15 API manufacturers and the 50 active pharmaceutical ingredients will be selected by the Medicines Control Division. Before DMA will inspect the actual API manufacturers, they will inspect the Danish manufacturers of finished products that use products from one of the 15 selected API manufacturers. These inspections will be short and solely focus on controlling the compliance with the rules by the API manufacturer in question. During these short inspections, it will be possible to discuss challenges and possible special risk areas related to the API manufacturers. Furthermore, DMA will review and discuss relevant audit reports.

In the first quarter of 2010, the Danish Medicines Agency will finish the project by holding an evaluation meeting for interested companies, where they present their findings, experience and possibilities for making the entire process more efficient. In addition, DMA will draw up an evaluation report, which gathers the findings and suggests improvements for the monitoring of API manufacturers. The report will be published at the Danish Medicines Agency's website.

Source: www.dkma.dk.

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