MHRA Revises Data Integrity Guidance

April 15, 2015

The document serves as guidance for the pharmaceutical industry in data integrity issues and complements existing EU GMP relating to APIs and dosage forms.

The United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA) has published a revised version of its “Data Integrity Guidance.” The document serves as guidance for the pharmaceutical industry in data integrity issues and complements existing EU GMP relating to APIs and dosage forms. The agency recommends that this guidance be read together with national medicines legislations and the GMP standards set out in Eudralex volume 4.

Data integrity is defined as the extent to which all data are complete, consistent, and accurate throughout the data lifecycle. The industry is expected to make arrangements to ensure that the accuracy, completeness, content, and meaning of data are retained throughout the data lifecycle.

MHRA’s initial publication of the data integrity guidance on Jan. 23, 2015 received high levels of interest from the industry and trade associations. The agency has responded to questions from stakeholders by providing additional clarifications to the text. The revised version is said to be more accurate in some places and partially appears more rigorous with regard to the agency’s expectations.