MHRA GxP Data Integrity Definitions and Guidance for Industry: New Draft Version for Consultation

In January and March 2015, the U.K. Medicines and Healthcare Products Regulatory Agency (MHRA) published a “GMP Data Integrity Definitions and Guidance for Industry”. The agency has recently published a new version of the Guidance. Please find here a short overview of the new features in the “GxP Data Integrity Definitions and Guidance for Industry: Draft version for consultation”.

http://www.gmp-compliance.org/enews_05505_MHRA-GxP-Data-Integrity-Definitions-and-Guidance-for-Industry-New-Draft-Version-for-Consultation_15637,15488,15420,15064,Z-COVM_n.html

In recent years, regulatory authorities have been struggling with data integrity issues. In particular the U.S. American FDA has tightened the awareness regarding the topic in many Warning Letters. In the meantime, data integrity has also become a focus of European regulatory authorities’ inspections. One of the first regulatory authorities to publish a “GMP Data Integrity Definitions and Guidance for Industry” in January and March 2015 was the U.K. Medicines and Healthcare Products Regulatory Agency (MHRA). More information can be found in “MHRA revises its Guideline on Data Integrity in the short Term