Data Integrity update following the MHRA industry consultative committee meeting for GMP and GDP

January 22, 2016 / by Paul Moran

MHRA_website_logo.jpgThe minutes from the October 2015 MHRA industry consultative committee meeting for GMP & GDP are now available on

Section 4.2.4 specifically details Data Integrity in which the MHRA reported on the work the GMP Inspectorate has carried out regarding data integrity.

From a GMP perspective, the GMP published guidance has not changed since the last meeting. Since that meeting a series of 3 articles relating to Data Integrity (DI) have been published on the inspectorate blog. These were written by David Churchward. The first one published in June looked at the impact of organisational culture upon data integrity issues. The second, published in July, explored the ALCOA acronym (attributable, legible, contemporaneous, original and accurate) and the final instalment published in August looked at the topics of performing “trial injections” within analysis runs and how the companies relying on each other within the supply chain can monitor data integrity to ensure they can rely on one another’s data.

In terms of inspections, inspectors are raising issues related to the DI guidance on site and continuing to present within a number of arenas on this topic.

The main in-house work at present on DI is working on a GxP guidance document applicable to GMP, GDP, GLP, GCP and GPvP. The inspectorate are conscious of the need for a consolidated guidance document that will apply across all GxPs as many companies, particularly on the laboratories side, work across a number of GxPs and there is an obvious need to be consistent across the board. A cross inspectorate group is working on this and it is hoped that guidance will be published within the next few months.

On an international level, the UK is the co-rapporteur for developing guidance on data integrity for EU GMP. This will probably be situated in Part 3 of EU GMP. It is being produced in conjunction with other international guidance (PIC/S and WHO) and also FDA guidance on the matter.

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Topics: Insider, News, Data Integrity

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.