MHRA GMP 数据完整性定义和行业指导原则 ，尘埃粒子在线监测系统应用中 数据完整性及cGMP合规性问题及建议
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。
以上是英国药监局数据完整性指南部分摘录，数据完整性系统建设对药企而言，是产品质量追溯的基石，是药品质量管理的必由之路。
相关推荐