# Guidance on GxP data integrity

Source: https://www.keypedia.com/records/uk_mhra_guidance/uk-mhra/1f4acc77-e280-4af5-918a-9056f79e4d3f
Type: Guidance
Published: March 9, 2018
Updated: September 27, 2021

> The Medicines and Healthcare products Regulatory Agency (MHRA) has issued comprehensive guidance regarding the implementation of compliant data governance systems across all GxP sectors, including laboratory, clinical, manufacturing, distribution, and pharmacovigilance practices. This guidance was developed to address recurring fundamental failures identified by the MHRA and international regulatory partners during routine inspections, which have frequently resulted in formal regulatory actions. Under the current regulatory framework, the MHRA clarifies that the 2021 OECD Advisory Document on Data Integrity now takes precedence for Good Laboratory Practice (GLP) facilities due to the United Kingdom's membership in the OECD Mutual Acceptance of Data System. Organizations are required to adopt these international standards while continuing to use the 2018 MHRA GXP Data Integrity Guidance as a supplemental resource to foster a strong internal data integrity culture. While the document does not name a specific company or individual inspection dates as it is a general regulatory resource, it mandates that all GxP-regulated entities establish robust governance systems and review additional guidance related to good practice during the COVID-19 pandemic. The primary required action for facilities is the alignment of their data management systems with these updated standards to ensure the accuracy and reliability of all regulatory data.

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## Content

The guidance is intended to be a useful resource on the core elements of a compliant data governance system across all GxP sectors (good laboratory practice, good clinical practice, good manufacturing practice, good distribution practice and good pharmacovigilance practice). It addresses fundamental failures identified by MHRA and international regulatory partners during GLP , GCP , GMP and GDP inspections; many of which have resulted in regulatory action. If you have any questions, please contact inspectorate@mhra.gov.uk Good Laboratory Practice ( GLP ) Since the release of the MHRA Guidance on GxP Data Integrity in March 2018 the OECD has issued an Advisory Document on Data Integrity (released 20 September 2021) which takes precedence over the MHRA GXP Data Integrity Guidance due to the UK’s membership of the OECD Mutual Acceptance of Data System. 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. Additional information for GLP Members . We have published multiple pieces of guidance on inspections and good practice in relation to the coronavirus (COVID-19) pandemic.

## Attachments

- [Guidance on GxP data integrity](https://assets.publishing.service.gov.uk/media/5aa2b9ede5274a3e391e37f3/MHRA_GxP_data_integrity_guide_March_edited_Final.pdf)