EMEA Publishes Update on a pilot project to collaborate on international GMP inspection activities

EMEA Publishes Update on a pilot project to collaborate on international GMP inspection activities (9 January 2009)
The objective of this paper is to provide an update on a proposal for more coordinated international planning of inspections, with particular focus on a pilot project for Active Pharmaceutical Ingredients taking into account risk based approaches, building on equivalent GMP standards and mutual confidence between international regulators.

• Pilot project to rationalise international GMP inspection activities - Rules of engagement and procedures for participating authorities (active pharmaceutical ingredients/active substances)