Regulatory & Safety

GettyImages/Waldemarus

BIOPRODUCTION CONGRESS DUBLIN 2017

HPRA tells drug makers how to get ‘GMP inspection-ready’

By Flora Southey

Firms should identify risks prior to inspection, make staff available during regulator visits, and respond promptly post-inspection when undergoing GMP site checks, says Ireland’s Health Products Regulatory Authority (HPRA).

Gettyimages/Ruskpp

MHRA pulls Evertogen's GMP certificate after inspection

By Gareth Macdonald

Evertogen Life Sciences Limited should recall drugs made at its facility in Mahabubnagar, India according to the MHRA, which identified critical quality and data integrity problems during an audit in August.