Update on the TGA - EMEA - FDA pilot project to rationalise international GMP inspection activities
January 2009
Earlier this year the TGA joined the US Food and Drug Administration (US FDA) and the European Medicines Agency (EMEA) to conduct a pilot project designed to facilitate collaboration of inspections of active pharmaceutical ingredient (API) manufacturers in third country locations.
The collaboration aims to enable participating agencies to leverage limited resources and cast a wider net over manufacturing standards in third country locations. This will be achieved through greater pre-audit communication, widening the scope of planned audits, and conducting joint inspections.
The project formally commenced in November 2008, with initial planning coordination now underway. For further details:
Update on a pilot project to collaborate on international GMP inspection activities (pdf,59kb)
<http://www.tga.gov.au/international/ecmra0901.pdf>
Rules of engagement and procedures for participating authorities (active pharmaceutical ingredients/active substances (pdf,77kb)
<http://www.tga.gov.au/international/ecmra0901rules.pdf>