MHRA GMP Data Integrity Definitions and Guidance for Industry March 2015

　　MHRA GMP 數據完整性定義和行業指導原則 2015 年 3 月

　　簡述:

　　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.

　　數據完整性是制藥質量體系確保藥品質量的基石。本文提供了 MHRA 對制藥行業 GMP 數據完整性方面的指導原則。本指導原則旨在對現有歐盟有關原料藥和藥物制劑的 GMP 進行補充說明，需結合國家藥品法規及頒布在 Eudralex 第四冊內的 GMP 標準進行閱讀理解。

　　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.

　　數據管理體系應該與歐盟 EU GMP 第一章所述的質量體系結合在一起。投入到數據管理的精力和資源應與其產品的風險等級相對應，同時還應該權衡其他質量保證工作的資源需求。因此, 生產者和分析實驗室并不是要刻板地進行常規的數據核對，而是要設計出并運行一套管理體系，來控制數據完整性的風險，而且詳細記錄這個體系合理性的支持依據。

　　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(紙質)數據和電子數據在數據完整性方面的要求是一致的。生產者和分析實驗室要意識到，從自動化/電腦系統回歸到手工(紙質)記錄的做法，并不能減少對數據完整性進行控制的要求。這反而會造成對條款 2001/83/EC 第 23 條的不符合，該條款要求企業根據科學和技術發展的狀況，采用普遍接受的科學的方法進行藥品生產和檢驗。

以上是英國藥監局數據完整性指南部分摘錄，數據完整性系統建設對藥企而言，是產品質量追溯的基石，是藥品質量管理的必由之路。

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