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Saturday, July 30, 2016

MHRA GxP Data Integrity Definitions and Guidance for Industry by gmp violations

MHRA GxP Data Integrity Definitions and Guidance for Industry


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.
The document should be read in conjunction with the applicable regulations and the general guidance specific to each GxP.
We welcome your comments via the comment sheet (MS Word Document,224KBwhich can be emailed to inspectorate@mhra.gsi.gov.uk
Click here for Document (PDF207KB14 pages)

Deadline for comments: 31 October 2016


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