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1、MHRA GMP Data Integrity Definitions and Guidance for Industry January 2015MHRA GMP 数据完整性定义和行业指导原则 1 月 2015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 expectati
2、ons for the pharmaceutical industry. This guidance is intended to complement existing EU GMP, and should be readin conjunction with national medicines legislation and the GMP standards published in Eudralex volume4.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 数据完整性的指导原则。本指导原则旨在对现有 EU GMP 进行补充说明，需结合国家药品
3、法规及 GMP 标准内 Eudralex 第四册进行阅读理解。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
4、 assurance resource demands. As such, manufacturers and analytical laboratories are not expected to implement a forensic approach to data checking, 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 wi
5、th supporting rationale.数据管理体系需要结合在 EU GMP 第一章描所述的质量体系中。投入到数据管理的精力和资源应与对应产品质量风险相称，同时也应权衡其他质量保证工作的资源需求，从而进行合理分配。因此，生产企业和分析实验室不是对数据进行刻板的核对，而是要设计并运行一个对数据完整性风险可控的管理体系，并完整地记载这样设计和运行的支持性理由。Data integrity requirements apply equally to manual (paper) and electronic data. Manufacturers and analytical laborat
6、ories 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 authorization holder to take accou
7、nt of scientific and technical progress and enable the medicinal product to be manufactured and checked by means of generally accepted scientific methods.数据完整性的要求同时适用于手工（纸质）数据和电子数据。生产企业和分析实验室要意识到从自动/电脑系统回归到手动/纸质记录体系，其本身并不会消除对数据完整性进行控制的要求。而且这也可能造成不符合条款2001/83 / EC 第23 条需要考虑科学和技术发展程度的要求，因为该要求企业确保药品能够以
8、普遍接受的科学方法进行生产和检验。Throughout this guidance, associated definitions are shown as hyperlinks.本指导原则所涉及的相关定义以超级链接连接的方式出现。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 trai
9、ning 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
10、of data lifecycle elements should be commensurate with its criticality in terms of impact to product quality attributes.除了一个包括对确保数据完整性至关重要的相应政策和人员培训的总体数据管理体系，同时应考虑在不同质量体系领域对构建性（如操作程序）和技术性（如计算机系统访问权限）控制手段的应用。对数据生命周期中各要素进行构建性和技术性控制的程度，要与其对产品质量属性影响关键程度相对应Data may be generated by (i) a paper-based recor
11、d of a manual observation, or (ii) in terms of equipment,a spectrum of simple machines through to complex highly configurable computerised systems. The inherent risks to data integrity may differ depending upon the degree to which data (or the system generating or using the data) can be configured,
12、and therefore potentially manipulated (see figure 1)数据可由以下几种情况产生：（i）人工观测的纸质记录，（ii）对于设备，由简单设备或复杂的高度可配置计算机系统产生的图谱。数据完整性的内在风险程度会有所不同，这取决于数据（或系统生成、使用数据）的可配置程度， 即被潜在处理的可能性（见图1）。Figure 1: Diagram to illustrate the spectrum of simple machine (left) to complex computerized system (right), and relevance of p
13、rintouts as original data图1：图示说明简单设备图谱（左）到复杂的计算机系统图谱（右），及将打印数据作为“初始数据”的对应关系With reference to figure 1 above, simple systems (such as pH meters and balances) may only require calibration, whereas complex systems require validation for intended purpose. Validation effort increases from left to right i
14、n the diagram above. However, it is common for companies to overlook systems of apparent lower complexity. Within these systems it may be possible to manipulate data or repeat testing to achieve a desired outcome with limited opportunity of detection (e.g. stand-alone systems with a user configurabl
15、e output such as FT-IR, UV spectrophotometers).参考图1，简单系统（诸如pH 计和天平）可能只需要校准，而复杂的系统需要“对预期用途进行验证”。验证活动在上图中从左到右相应加强。但是，企业常常容易忽视一些貌似并不复杂的系统。在此类系统中，有可能通过处理数据或重复检测以获取期望的结果，并且不容易被发现（例如带有用户可配置输出功能单机版设备，如FT-IR，UV 分光光度计）。Designing systems to assure data quality and integrity系统化设计以确保数据质量和完整性Systems should be de
16、signed in a way that encourages compliance with the principles of data integrity.Examples include:系统的设计应遵循数据完整性的原则包括以下： Access to clocks for recording timed events 对用作记录以时间为顺序事件的计时器进行权限控制 Accessibility of batch records at locations where activities take place so that ad hoc datarecording and later transcription to official records is not necessary 将记录放置在生产现场，避免不必要的临时记录数据然后事后誊成正式记录 Control over blank paper templates for data recording对用于数据记录的纸质空白模板进行控制 User access rights which
