MHRA publishes GXP data integrity guide

The Medicines and Healthcare Products Regulatory Agency (MHRA) has published a GXP data integrity guide. GXP encompasses various good practices regulated by the UK MHRA, including the Good Laboratory Practice Monitoring Authority (GLPMA). These are Good Clinical Practice (GCP), Good Distribution Practice (GDP), Good Laboratory Practice (GLP), Good Manufacturing Practice (GMP) and Good Pharmacovigilance Practice (GPvP). The guidance aims to provide useful information on the core elements of a compliant data governance system across all GXP sectors.

The guide addresses fundamental failures identified by the MHRA and international regulatory partners during GLP, GCP, GMP and GDP inspections, of which many have resulted in regulatory action. During the consultation process, over 1300 comments were received from industry, and trade and professional groups across all GXPs. As there was such a high degree of engagement, an extended period of review by the MHRA’s GXP data integrity team formed from GCP, GDP, GLP, GMP and GPvP inspection groups was required. The MHRA has stated that the resulting document reflects the high degree of engagement between MHRA and the industry that it regulates.

The GXP data integrity guidance has a high degree of alignment with documents published by other regulators such as the World Health Organisation (WHO) and the European Medicines Agency (EMA). The guidance aims to facilitate compliance through education, whilst helping to clarify the MHRA’s position on data integrity and the minimum expectation to achieve compliance.

To view the MHRA’s ‘GXP’ data integrity guidance and definitions, please click here.