The minutes from the October 2015 MHRA industry consultative committee meeting for GMP & GDP are now available on www.gov.uk.

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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