MHRA的GMP数据完整性定义和行业指南 (2015年3月发布).pdf

Soltoris Management Consultants, Inc. 洛施德企业管理咨询（上海）有限公司 MHRA GMP Data Integrity Definitions and Guidance for Industry March 2015 MHRA 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，它保证药品具有所需要的质量。本文件向制药行业提供 MHRA 关 于GMP 数据完整性方面期望的指南。本指南意在对现有关于活性物质和制剂的EU GMP 进行补充，应与国家 药监法规和欧洲法规第4 卷的GMP 标准联合解读。 The data governance system should be integral to the pharmaceutical quality system described in EU GMP chapter 1. The effort and resource assigned to data governance should be commensurate with the risk to product quality, and should also be balanced with other quality assurance resource demands. As such, manufacturers and analytical laboratories are not expected to implement a forensic approach to data checking on a routine basis, but instead design and operate a system which provides an acceptable state of control based on the data integrity risk, and which is fully documented with supporting rationale. 数据管理系统应与 EU GMP 第1 章中描述的药品质量体系相结合。给数据管理提供的努力和资源应与产品质量 的风险相称，还应与其它质量保证资源需求相平衡。因此，并不期待生产商和分析实验室实施一种辩论的方 法来对数据进行常规检查，而只需要设计和实施一种系统，提供一种基于数据完整性风险的可接受控制状态， 并对支持性理由进行完整记录。 Data integrity requirements apply equally to manual (paper) and electronic data. Manufacturers and analytical laboratories should be aware that reverting from automated / computerised to manual / paper-based systems will not in itself remove the need for data integrity controls. This may also constitute a failure to comply with Article 23 of Directive 2001/83/EC, which requires an authorisati