2015年3月 MHRA GMP 数据完整性定义和行业指导原则.pdf

Data Integrity Definitions and Expectations Revision 1.1 1 数据完整性定义与期望 March 2015 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 cons