The MHRA published the GXP Data Integrity Guidance in March 2018 (see https://mhrainspectorate.blog.gov.uk/2018/03/09/mhras-gxp-data-integrity-guide-published/) and has subsequently led the development of an Organisation for Economic Co-Operation and Development (OECD) advisory document on data integrity.
The new OECD Data Integrity Advisory Document can be found here: https://www.oecd.org/officialdocuments/publicdisplaydocumentpdf/?cote=env/cbc/mono(2021)26&doclanguage=en
The OECD Advisory Document on Data Integrity takes precedence over the MHRA GXP Data Integrity Guidance, due to the UK’s membership of the OECD Mutual Acceptance of Data (MAD) System (further details on the international GLP framework can be found here (Being signed up to the OECD Mutual Acceptance of Data agreement is anything but MAD! - MHRA Inspectorate (blog.gov.uk)).
The MHRA GXP Data Integrity Guidance was always intended to sit alongside additional regulatory guidance and should also continue to be used to supplement and support UK GLP facilities as it provides additional guidance primarily associated with the importance of a supportive organisational culture in order to embed and foster a strong data integrity culture within organisations.
While the keen-eyed among you will notice similarities between the MHRA data integrity document and the OECD advisory document, there are a number of differences between the 2 sets of guidance. There are a few additional requirements, but these tend to complement the existing MHRA guidance and no significant contradictions exist between the 2 documents. As a result, there are no plans to revise the MHRA document at this time.
The differences can be summarised into the following groups of changes (this is not an exhaustive list, organisations should conduct their own review and assess the changes required and any impact on existing practices):
Making the guidance specific for Good Laboratory Practice (GLP)
- the use of terminology associated with GLP (examples include ‘raw data’ instead of ‘source data’, the use of ‘Test Facility Management’ and ‘Study Director’)
- reference to existing OECD guidance such as OECD Documents No 1 (OECD Principles on Good Laboratory Practice), No 15 (Establishment and Control of Archives that Operate in Compliance with the Principles of GLP), No 16 (Guidance on the GLP Requirements for Peer Review of Histopathology) and No 17 (Application of GLP Principles to Computerised Systems)
- changes to language within the data integrity document to reflect existing language and definitions from other OECD documents
- addition of GLP examples
Definitions and guidance
- the addition of definitions for 'Derived Data', 'Flat Files' and 'Relational Database'
- differences between some definitions for example 'Raw Data', 'Electronic signatures' and 'Metadata'
- change of definition of Complete, Consistent, Enduring and Available (CCEA) requirements
Additional content
- additional subject areas such as Data Recording and Handling, Verified Copies and Archiving
Members of the UK GLP Monitoring Programme should conduct a documented review of their existing data integrity processes against the OECD document to ensure that they fully comply and that any required changes or additions are implemented. This activity is likely to be reviewed at the next inspection of the facility.
Please contact the Laboratories Inspectorate via the mailbox (gxplabs@mhra.gov.uk ) if you need further clarification of any of the changes as a result of the release of the new OECD Document.
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