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Final report on the International API inspection Pilot Programme

Executive summary

A pilot programme on International collaboration on GMP inspections of API manufacturers was conducted between December 2008 
and December 2010 involving competent authorities from Australia, Europe and the United States. The purpose of the programme
was to foster cooperation and mutual confidence between participating regulators through better communication and exchange of information
on inspection planning.

New tools for work sharing and exchange of information were developed and used by the participants to share inspection reports and
to organise joint inspections of API manufacturers located outside the participating regions. Increased transparency and visibility of inspections
performed by participating authorities allowed a successful collaboration between authorities on sites of common interest and increased
the number of inspections performed of value to more than one authority.

Following the successful conclusion of the pilot it was agreed to maintain the cooperation established and to extend participation,
initially to other European authorities.

The increased cooperation established as a result of this pilot programme increased information sharing between the regulators concerned
and facilitated work sharing. It also promoted more efficient use of international inspectional resources combined with wider global inspectional
coverage to the benefit of public health and patients worldwide.

More information on these joint programmes can be found at:



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