英国药监局(MHRA)发布数据完整性指南 2015.03

MHRA GMP Data Integrity Definitions and Guidance for Industry March 2015

MHRA GMP 数据完整性定义和行业指导原则2015年3月

简述:

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.

数据完整性是制药质量体系确保药品质量的基石。本文提供了MHRA对制药行业GMP数据完整性方面的指

导原则。本指导原则旨在对现有欧盟有关原料药和药物制剂的GMP进行补充说明，需结合国家药品法规及

颁布在Eudralex 第四册内的GMP标准进行阅读理解。

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.

数据管理体系应该与欧盟EU GMP第一章所述的质量体系结合在一起。投入到数据管理的精力和资源应

与其产品的风险等级相对应，同时还应该权衡其他质量保证工作的资源需求。因此, 生产者和分析实验室

并不是要刻板地进行常规的数据核对，而是要设计出并运行一套管理体系，来控制数据完整性的风险，而

且详细记录这个体系合理性的支持依据。

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 authorisation holder to take account of scientific and

technical progress and enable the medicinal product to be manufactured and checked by means

of generally accepted scientific methods.

手工（纸质）数据和电子数据在数据完整性方面的要求是一致的。生产者和分析实验室要意识到，从

自动化/电脑系统回归到手工（纸质）记录的做法，并不能减少对数据完整性进行控制的要求。这反而

会造成对条款2001/83/EC第23条的不符合，该条款要求企业根据科学和技术发展的状况，采用普遍

接受的科学的方法进行药品生产和检验。

Throughout this guidance, associated definitions are shown as hyperlinks.

本指导原则所涉及的相关定义可以点下面的链接。

Establishing data criticality and inherent integrity risk:

建立数据的关键程度和内在的完整性风险：

In addition to an overarching data governance system, which should include relevant policies and staff training in the importance of data integrity, consideration should be given to the organisational (e.g. procedures) and technical (e.g. computer system access) controls applied to different areas of the quality system. The degree of effort and resource

applied to the organisational and technical control of data lifecycle elements should be commensurate with its criticality in terms of impact to product quality attributes.

仅仅靠一个总体的数据管理体系是不够的，虽然已包括了对数据完整性至关重要的相应的方针和人员培训，还应该考虑在不同的质量体系领域采用组织性的控制手段（如操作程序）和技术控制手段（如计算机系统