EMA, FDA and TGA joint GMP inspection programme

INICIO/Directrices | Posted 13/05/2011 post-comment0 Post your comment

On 27 April 2011, the FDA announced that it is working with the EMA and Australia’s Therapeutic Goods Administration (TGA) to finalise a permanent pilot programme for joint good manufacturing practice (GMP) inspections at active pharmaceutical ingredient (API) manufacturing facilities.


The objective of the collaboration on GMP inspections is to spread the workload, allowing more API sites to be monitored.

The EMA and FDA had already announced a pilot programme for joint GMP inspections in August 2010 and had prepared a draft procedure for such a joint venture in September 2010. Adding Australia’s TGA to the collaboration will certainly help to spread their resources further, enabling even more sites to be inspected.

The idea of collaboration to lighten the load is not new for the EMA and FDA. The agencies launched a three year pilot programme on 1 April 2011 that will allow parallel evaluation of quality elements, known as Quality by Design, of selected applications that are submitted to both agencies at the same time.

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FDA and EMA to join forces on quality

Source: EMA, FDAnews

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