In breaking news today, the MHRA just released a new 14 page consultation document for data integrity. As quoted from the MHRA:
"During this busy period we have also been working on the next phase of MHRA guidance, which has a GxP focus (good laboratory practice, good clinical practice, good manufacturing practice, good distribution practice and good pharmacovigilence practice). 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."
The MHRA continues to state in a blog released today to support the consultation document, "Data integrity is everyone’s responsibility. There will therefore be a three-month public consultation on the GxP guidance which is your opportunity to engage with MHRA in developing guidance."
To read more about this breaking update from the MHRA, view the following:
MHRA has produced draft GxP data integrity guidance for industry and we welcome your comments