GMP Data Integrity Definitions

The regulatory authority MHRA has issued guidance on GMP Data Integrity Definitions. Data integrity is fundamental in a pharmaceutical quality system which ensures that medicines are of the required quality.

The new paper stated: “This document provides MHRA guidance on GMP data integrity expectations for the pharmaceutical industry. This guidance is intended to complement existing EU GMP relating to active substances and dosage forms, and should be read in conjunction with national medicines legislation and the GMP standards published in Eudralex volume 4.”

The paper can be accessed here.

Posted by Tim Sandle