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发表于 2015-1-31 20:26:00
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MHRA的GMP数据完整性定义和行业指南/2015年1月（Julia翻译）
MHRA的GMP数据完整性定义和行业指南/2015年1月（未完待续）
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辩论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，该条款要求自动化的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。
Throughout this guidance, associated definitions are shown as hyperlinks.
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 data governance system, which should include relevant policies and staff training 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 of data lifecycle elements should be commensurate with 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顶端数据管理系统外，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。
Data may be generated by (i) a paper-based record 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, 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，简单设备通过复杂的高级参数计算机化系统产生的图谱。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）。
201501 MHRA数据完整性指南 - Julia - 成功是永远的追逐，追逐是永远的成功
201501 MHRA数据完整性指南 - Julia - 成功是永远的追逐，追逐是永远的成功
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 in 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 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，公司一般需要对明显的较低复杂程度的系统进行验看。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色谱仪）。
Designing systems to assure data quality and integrity
设计系统来保证数据质量和完整性
Systems should be designed in a way that encourages compliance with the principles of data integrity. Examples include:
系统设计方式应鼓励符合数据完整性性原则：
l Access to clocks for recording timed events
l 记录事件时间的时钟进入权限
l 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
l 让批记录摆放在活动进行的当地，这样就不需要临时数据记录然后转抄至正式记录
l Control over blank paper templates for data recording
l 数据记录所用的空白纸模板控制
l User access rights which prevent (or audit trail) data amendments
l 用户权限能防止（或审计追踪）数据修改
l Automated data capture or printers attached to equipment such as balances
l 仪器，如天平，附带的自动获取或打印数据设施
l Proximity of printers to relevant activities
l 打印机与相关活动邻近
l Access to sampling points (e.g. for water systems)
l 取样点进入权限（例如，水系统）
l Access to raw data for staff performing data checking activities.
l 员工进行数据检查时进入原始数据的权限
The use of scribes to record activity on behalf of another operator should be considered ‘exceptional’, and only take place where:
使用专门记录人员来代表另一个操作人员记录所实施的活动应只在例外下才考虑和发生，如
l The act of recording places the product or activity at risk e.g. documenting line interventions by sterile operators.
l 记录行为会使得产品或活动产生风险，例如，由无菌操作者进行静脉注射剂的生产线记录
l To accommodate cultural or staff literacy / language limitations, for instance where an activity is performed by an operator, but witnessed and recorded by a Supervisor or Officer.
l 陪同培养或员工文字/语言受限时，如一种活动由操作人员实施，但由主管或管理人员进行证明和记录
In both situations, the supervisory recording must be contemporaneous with the task being performed, and must identify both the person performing the observed task and the person completing the record. The person performing the observed task should countersign the record wherever possible, although it is accepted that this countersigning step will be retrospective. The process for supervisory (scribe) documentation completion should be described in an approved procedure, which should also specify the activities to which the process applies.
在两种情形下，主管记录必须与所实施的任务同步进行，且必须识别观察任务和完成记录的人的身份。只要可能，进行观察工作的人应会签记录。监管（记录）文件记录完成的过程应在一个批准程序里进行描述，还应说明该程序适用的活动。
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虽然不是回复可见，但是还是要感谢分享。
发表于 2015-1-31 20:45:01
由这个条款看来， 很多公司的只用打印图谱作为记录，而对电子记录没有管理的做法将越来越难被接受了。这个是很多国内准备出口企业的一个关注点。
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