The integrity of all GxP data used to ensure the quality and efficacy of drugs is paramount to a drug’s safety and efficacy and can have a great impact on public health. To that point, the MHRA has published a draft version for consultation of a guidance titled “MHRA GxP Data Integrity Definitions and Guidance for Industry” This draft is intended to update and broaden the scope of the existing March 2015 “MHRA Data Integrity Definitions and Guidance for Industry” to all GxP data. This draft also cites the principles of ICH Q9 “Quality Risk Management”, and the importance of senior management’s role in establishing a data governance system documenting expectations and processes that encourage and assure compliance with the data integrity principles. The draft Guidance indicates that a corporate Data Governance System should target establishing“an acceptable state of control based on the data integrity risk with supporting rationale.”
The draft Guidance also provides clarification around specific expectations and detailed guidance on many aspects of data integrity beyond those described in the March 2015 guidance document. Of specific value is the discussion on static and dynamic forms of original data records and the need to retain the complete data in its original form. The guidance on audit trail requirements and data review activities are also expected to be very helpful to the pharmaceutical industry.
Although MHRA is sharing this document as a draft version for consultation, and Lachman encourages input to the process, the draft document provides great insight into the current regulatory thinking on the topic of GxP Data Integrity.
For further information and training on the topic of data integrity in the pharmaceutical industry and the importance of taking a proactive approach, please contact either R. George, Ph.D. at firstname.lastname@example.org or J. Davidson, Ph.D. at email@example.com .