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MHRA Creates Draft GxP Data Integrity Guidance

July 21, 2016 / by Paul Moran

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

MHRA data integrity guidance: 18 months on

labhq lims leaflet free download

Topics: Data Integrity, GxP, MHRA

Paul Moran

Written by Paul Moran

Dr. Paul Moran is the founder of Broughton Laboratories Ltd and Broughton Software Ltd who serves as their Chief Executive. As a chemistry graduate with a PhD in Biotechnology, Paul began his career at the US pharmaceutical manufacturer Johnson and Johnson. In his role as QC Laboratories Manager, Paul obtained Six Sigma Black Belt certification. Paul entered the world of contract QC testing in 2003 supporting the successful growth of a contract laboratory leading to its merger in 2005. Paul started his first venture in 2006, establishing Broughton Laboratories as one of the leading UK MHRA and US FDA GMP licensed contract laboratories with its own dedicated stability storage facility which opened in 2011. The spin-off company, Broughton Software, was established in 2012 to provide a LIMS solution for regulated QC Laboratories. LabHQ LIMS launched its 4th release in September 2015.

   

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