Guidance

Guidance on GxP data integrity

This 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.

Documents

Guidance on GxP data integrity

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Details

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.

If you have any questions, please contact inspectorate@mhra.gov.uk

Good Laboratory Practice (GLP)

Since the release of the MHRA Guidance on GxP Data Integrity in March 2018 the OECD has issued an Advisory Document on Data Integrity (released 20 September 2021) which takes precedence over the MHRA GXP Data Integrity Guidance due to the UK’s membership of the OECD Mutual Acceptance of Data System.

The MHRA GXP Data Integrity Guidance was always intended to sit alongside additional regulatory guidance and should also continue to be used to supplement and support UK GLP facilities as it provides additional guidance primarily associated with the importance of a supportive organisational culture in order to embed and foster a strong data integrity culture within organisations.

Additional information for GLP Members.

We have published multiple pieces of guidance on inspections and good practice in relation to the coronavirus (COVID-19) pandemic.

Published 9 March 2018
Last updated 27 September 2021 + show all updates
  1. Added new information titled 'Good Laboratory Practice (GLP)'.

  2. First published.