News about GMP/cGMP


MHRA: Consultation Document to GxP Data Integrity

The international hot topic of data integrity continues to develop. Eighteen months after releasing its GMP data integrity guidance, the MHRA (Medicines and Healthcare Products Regulatory Agency, UK) has now published a revision thereof. The draft document entitled GxP data integrity definitions and guidance for industrycomprises 14 pages and can be seen as the next phase of MHRA guidance.


Data integrity is important throughout the pharmaceutical lifecycle, and GxP regulatory requirements have a common focus of requiring confidence in the quality and the integrity of the data used for decision-making. As media reports and regulator websites continue to describe serious data integrity failures in clinical trial conduct and laboratory practice as well as in medicines manufacture, the MHRA classifies the availability of GxP guidance an important step forward.

The 14-pages 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 intention behind the guidance is to provide 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).

According to MHRA, it addresses fundamental failures identified by the agency and international regulatory partners during GLP, GCP, GMP and GDP inspections. The document is to be read in conjunction with the applicable regulations and the general guidance specific to each GxP. In common with other regulatory partners, the MHRA has cross referenced to other relevant guidance, to avoid repetition. The revision contains less GMP-specific examples than the 2015 guidance. Instead examples applicable to more than one regulated area were used. The principles of data governance can be seen as very similar across all areas of the pharmaceutical lifecycle.

The document is open for comments until October 31, 2016. The MHRA expressly encourages in taking the opportunity to contribute to this important initiative, for data integrity is everyone’s responsibility.


MHRA: News Story



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