MHRA数据完整性指南.docxVIP

MHRA GMP Data Integrity Definitions and Guidance for Industry March 2015MHRA的GMP数据完整性定义和行业指南/2015年3月Introduction: 背景介绍Data integrity is fundamental in a pharmaceutical quality system which ensures that medicines are of the required quality. 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.数据完整性在药品质量体系中是基本要求，它保证药品具有所