MHRA GMP Data Integrity Definitions and Guidance for Industry
Title:
MHRA GMP Data Integrity Definitions and Guidance for Industry
Origin/Publisher:
MHRA
Content:
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.