Bioequivalence and Bioavailability Forum

Dear All,

MHRA has produced draft GxP data integrity guidance for industry

This consultation document 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.

The guidance is intended to be a useful resource on the core elements of a compliant data governance system across all GxP sectors (good laboratory practice, good clinical practice, good manufacturing practice, good distribution practice and good pharmacovigilance practice).

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.

MHRA welcome comments via the comment sheet which can be emailed to [email protected]

Deadline for comments: 31 October 2016

Kindly refer below link for guidance document...,

https://www.gov.uk/government/news/mhra-gxp-data-integrity-definitions-and-guidance-for-industry