EMEA: Inspections Website Update

European Medicines Agency (EMEA) Inspections website has been updated and includes web pages on Process Analytical Technology (PAT). PAT is a system for designing, analysing, and controlling manufacturing through timely measurements of critical quality and performance attributes of raw and in-process materials and processes with the goal of ensuring final product quality. This definition is taken from FDA's recently finalised guideline and will be used by European regulators to avoid confusion. An EMEA PAT team was created in January 2004 to review the implications of PAT to ensure that the European regulatory framework and the authorities are prepared for and adequately equipped to conduct thorough and effective evaluations of PAT-based submissions.