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MHRA’s GXP data integrity guide published

The MHRA’s GXP data integrity guide has been published today.

‘GXP’ refers to the various good practices regulated by the UK MHRA, including the Good Laboratory Practice Monitoring Authority (GLPMA). These are Good Clinical Practice, Good Distribution Practice, Good Laboratory Practice, Good Manufacturing Practice and Good Pharmacovigilance Practice.

There has been significant stakeholder interest in the development of the guide, as illustrated by the receipt of over 1300  comments from industry, and trade and professional groups across all GXPs during the consultation process. Such a high degree of engagement required an extended period of review by the MHRA’s GXP data integrity team formed from our GCP, GDP, GLP, GMP and GPvP inspection groups. The team has done a great job in carefully considering the important stakeholder feedback, while balancing our other inspectorate commitments. I am confident that the resulting document reflects the high degree of engagement between MHRA and the industry that we regulate.

The GXP data integrity guidance has a high degree of alignment with documents published by other regulators such as PIC/S, WHO, OECD (guidance and advisory documents on GLP) and EMA. It is designed to facilitate compliance through education, whilst clarifying the MHRA’s position on data integrity and the minimum expectation to achieve compliance.

MHRA continues to engage with stakeholders in this important issue.

Aerial view of a laptop and paperwork

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  1. Comment by Ian posted on

    If this is "Revision 1" does it relate to Revision 1 published Jan-2015 and Revision 1.1 published Mar-2015. Why is this not Revision 2?

    • Replies to Ian>

      Comment by Tracy Moore posted on

      The GMP Data Integrity guide was first issued in January 2015 before being updated in March 2015. The GXP Data Integrity guide is new and the first published version of guidance of this scope.

  2. Comment by Steven Brown posted on

    Can you please confirm that the 2015 Data Integrity Guidance issued by MHRA is still valid, or if it has now been superseded by the recently issued guidance.
    Many thanks for the work on the updated guidance, it is appreciated, given that there was a considerable number of comments to go through.

    • Replies to Steven Brown>

      Comment by Tracy Moore posted on

      The GXP Data Integrity guidance document superseded the GMP Data Integrity guide of March 2015.

      • Replies to Tracy Moore>

        Comment by Steve posted on

        Thanks for your response, appreciated.