MHRA指南-数据完整性(中英文)

MHRA指南-数据完整性

MHRA GMP Data Integrity Definitions and Guidance for Industry January 2015

MHRA的GMP数据完整性定义和行业指南/2015年1月

Introduction: 背景介绍

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, and should be read in conjunction with national medicines legislation and the GMP standards published in Eudralex volume 4.

数据完整性在药品质量体系中是基本要求，它保证药品具有所需要的质量。本文件向制药行业提供MHRA关于GMP数据完整性方面期望的指南。本指南意在对现有EU GMP进行补充，应与国家药监法规和欧洲法规第4卷的GMP标准联合解读。

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, 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.

数据管理系统应与EU GMP第1章中描述的药品质量体系相结合。给数据管理提供的努力和资源应与产品质量的风险相称，还应与其它质量保证资源需求相平衡。因此，并不期待生产商和分析实验室实施一种司法鉴定的方法来对数据进行检查，而只需要设计和实施一种系统，提供一种基于数据完整性风险的可接受控制状态，并对支持性理由进行完整记录。

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.

数据完整性要求等同适用于手工（纸质）和电子数据。生产商和分析化验室应明白将自动化的/计算机化的系统转换为人工/纸质的系统并不能消除数据完整性控制的需求。这可能也会是违反法条2001/83/EC第23款的，该条款要求许可证持有者要考虑科学技术进步，使得药品采用普遍被接受的科学方法进行生产和检查。

在本指南全篇中相关定义均采用了超链接显示。

Establishing data criticality and inherent integrity risk: 建立数据关键性和内在完整性风险

In addition to an overarching

MHRA指南-数据完整性

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

its criticality in terms of impact to product quality attributes.

除了包括相关方针和员工关于数据完整重要性培训的总体数据管理系统外，还要考虑将组织性（例如，程序）和技术性（例如，计算机系统进入权限）控制应用于质量体系的不同领域。应用于组织性和技术性控制数据生命周期要素的努力程度和资源配置情况应与其对产品质量属性的影响关键性相适应。

equipment, a spectrum of simple machines through to complex highly configurable computerised systems. The inherent risks to differ depending upon the degree to which data (or the system generating or using the data) can be configured, and therefore potentially manipulated (see figure 1).

数据可以由以下方式产生（1）人工观察纸质记录（2）仪器，一连串简单仪器直到复杂的高度可配置的计算机系统。数据完整性的内在风险根据数据可设置参数水平不同而不同，因此是可以捏造的（参见图1）。

（蒲公英论坛原创翻译） 图1：表示简单仪器（左边）与复杂计算机化系统（右边）的图谱，及打印数据作为“原始数据”的相关性

简单 复杂

LC-MS

MHRA指南-数据完整性

pH计 过滤器完整性测试仪

UV光谱仪 HPLC系统 LIMS系统 ERP系统 FT-IR CAPA系统

无软件 简单软件 复杂软件

打印 打印不具有代表性 可以代表原始数据

（图示知识格林山QA LLC）

With reference to figure 1 above, simple systems (such as pH meters and balances) may only require calibration, whereas complex systems require ‘Validation effort increases from left to right in the diagram above. However, it is common for companies to overlook systems of apparent lower complexity. Within these systems it may be opportunity of detection (e.g. stand-alone systems with a user configurable output such as FT-IR, UV spectrophotometers).

参考上述图1，简单系统（例如pH计和天平）可能只要求进行校正，而复杂系统则需要进行“对其既定用途进行验证”。验证工作在上图中从左到右逐步增加。但是，公司一般需要会忽略较低复杂程度的系统。在这些系统中，可能会可以捏造数据或重复测试以达到所想要的结果，而被发现的机会较低（例如，独立系统具有用户可设置参数的输出，例如，FT-IR，UV分光光度计）。

Designing systems to assure data quality and integrity 设计系统来保证数据质量和完整性

系统设计方式应鼓励符合数据完整性性原则： Access to clocks for recording timed events 记录事件时间的时钟进入权限

Accessibility of batch records at locations where activities take place so that ad hoc data

recording and later transcription to official records is not necessary 在活动进行的当地处理批记录，这样就不需要临时数据记录然后转抄至正式记录 Control over blank paper templates for data recording 控制数据记录所用的空白纸模板

用户权限能防止（或审计追踪）数据修改

Automated data capture or printers attached to equipment such as balances

MHRA指南-数据完整性

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