MHRA GMP Data Integrity Definitions and Guidance for Industry March 2015

　　MHRA GMP 數(shù)據(jù)完整性定義和行業(yè)指導(dǎo)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(shù)據(jù)完整性是制藥質(zhì)量體系確保藥品質(zhì)量的基石。本文提供了 MHRA 對制藥行業(yè) GMP 數(shù)據(jù)完整性方面的指導(dǎo)原則。本指導(dǎo)原則旨在對現(xiàn)有歐盟有關(guān)原料藥和藥物制劑的 GMP 進(jìn)行補(bǔ)充說明，需結(jié)合國家藥品法規(guī)及頒布在 Eudralex 第四冊內(nèi)的 GMP 標(biāo)準(zhǔn)進(jìn)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(shù)據(jù)管理體系應(yīng)該與歐盟 EU GMP 第一章所述的質(zhì)量體系結(jié)合在一起。投入到數(shù)據(jù)管理的精力和資源應(yīng)與其產(chǎn)品的風(fēng)險等級相對應(yīng)，同時還應(yīng)該權(quán)衡其他質(zhì)量保證工作的資源需求。因此, 生產(chǎn)者和分析實驗室并不是要刻板地進(jìn)行常規(guī)的數(shù)據(jù)核對，而是要設(shè)計出并運(yùn)行一套管理體系，來控制數(shù)據(jù)完整性的風(fēng)險，而且詳細(xì)記錄這個體系合理性的支持依據(jù)。

　　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(zhì))數(shù)據(jù)和電子數(shù)據(jù)在數(shù)據(jù)完整性方面的要求是一致的。生產(chǎn)者和分析實驗室要意識到，從自動化/電腦系統(tǒng)回歸到手工(紙質(zhì))記錄的做法，并不能減少對數(shù)據(jù)完整性進(jìn)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(yè)根據(jù)科學(xué)和技術(shù)發(fā)展的狀況，采用普遍接受的科學(xué)的方法進(jìn)行藥品生產(chǎn)和檢驗。

以上是英國藥監(jiān)局?jǐn)?shù)據(jù)完整性指南部分摘錄，數(shù)據(jù)完整性系統(tǒng)建設(shè)對藥企而言，是產(chǎn)品質(zhì)量追溯的基石，是藥品質(zhì)量管理的必由之路。

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