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Focus on Regulation

MHRA Published New GMP Data Integrity Guidance

The UK medicines regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), has published new guidance on data integrity in the context of good manufacturing practices (GMP).

Data integrity forms a key part of pharmaceutical quality systems. According to the MHRA guidance, the purpose of data integrity is to ensure that the accuracy, completeness, content, and meaning of data is retained throughout the data lifecycle. The MHRA already requires pharmaceutical manufacturers and analytical laboratories to review their governance systems to ensure data integrity as part of their GMP self-inspection program, in line with EU GMP legislation and standards, such as the GMP Directive and the European Commission Guidance in EudraLex Volume 4.

The new guidance, which applies to data in both hardcopy and electronic format, provides further clarity as to the MHRA’s expectations, including:

  • in addition to policies and staff training on data integrity, consideration should be given to organizational (i.e. procedures) and technical (e.g. computer system access) controls within a data governance system; and
  • the design and operation of data governance systems should be proportionate with the risk to product quality and manufacturers should document the supporting rationale for the level of effort and resource they assigned to their system.

The guidance also sets out definitions and guidance for a number of terms, including “data”, “raw data”, “metadata”, “data governance”, “data integrity”, “data retention” and “audit trail”.

The publication of this guidance indicates the increasing importance that the MHRA is placing on data integrity in ensuring the quality of medicines. For further information visit https://www.gov.uk/government/publications/good-manufacturing-practice-data-integrity-definitions.