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.
The document should be read in conjunction with the applicable regulations and the general guidance specific to each GxP.
The way in which regulatory data is generated has continued to evolve in line with the introduction and ongoing development of supporting technologies, supply chains and ways of working.
Systems to support these ways of working can range from manual processes with paper records to the use of computerised systems. However the main purpose of the regulatory requirements remains the same; having confidence in the quality and the integrity of the data generated and being able to reconstruct activities remains a fundamental requirement.