
MHRA - GxP Data Integrity Guidance for Industry
MHARA has publised GxP data integrity guidance for the industry. It addresses fundamental failures identified by MHRA and international regulatory partners during GLP, GCP, GMP and GDP inspections; many of which have resulted in regulatory action.
This document (PDF, 207KB, 14 pages) provides guidance on the data integrity expectations that should be considered by organisations involved in any aspect of the pharmaceutical lifecycle or GLP studies regulated by MHRA.