WHO《数据完整性指南》-2021（中英文对照版）.doc

WHO《数据完整性指南》-2021（中英文对照版） 3月29日，WHO发布了第 55 届药物制剂规范专家委员会（ECSPP）技术报告TRS?No.1033，其中包含新的《数据完整性指南》，翻译如下，分享给大家！ Guideline on data integrity 数据完整性指南 1. Introduction and background 介绍和背景 1.1. In recent years, the number ofobservations made regarding the integrity of data, documentation and recordmanagement practices during inspections of good manufacturing practice (GMP) (2),good clinical practice (GCP), good laboratory practice (GLP) and Good Trade andDistribution Practices (GTDP) have been increasing. The possible causes forthis may include 近年来，在对良好生产规范(GMP)(2)、良好临床规范(GCP)、良好实验室规范(GLP)和良好贸易和分销规范(GTDP)的检查过程中，对数据完整性、文件和记录管理规范的缺陷数量持续增加。可能的原因包括： (ⅰ) reliance on inadequate human practices; 依赖于不适当的人员操作; (ⅱ)poorly defined procedures; 规定糟糕的规程 (ⅲ)resource constraints; 资源限制 (ⅳ) the use of computerized systems that are not capable of meetingregulatory requirements or are inappropriately managed and validated (3, 4); 使用不满足法规要求，或管理/验证不当的计算机系统(3,4); (ⅴ) inappropriate and inadequate control of data flow; and 不适当和不充分的数据流控制;和 (ⅵ)failure to adequately review and manage original data and records. 未能充分审核和管理原始数据和记录。 1.2. Data governance and related measures shouldbe part of a quality system, and are important to ensure the reliability ofdata and records in good practice (GxP) activities and regulatory submissions.The data and records should be attributable, legible, contemporaneous,original’ and accurate, complete, consistent, enduring, and available; commonlyreferred to as “ALCOA+”. 数据治理和相关措施应该是质量体系的一部分，对于确保GxP活动和法规申报中的数据和记录的可靠性非常重要。数据和记录应是“可归属的、易读的、同步的、原始的”、准确的、完整的、一致的、持久的和可用的;通常称为“ALCOA+”。 1.3. This document replaces the WHO Guidanceon good data and record managementpractices (Annex 5, WHO Technical Report Series, No. 996, 2016) (1). 本文件取代了《WHO良好数据和记录管理规范指南》(WHO技术报告系列，No. 996, 2016，附件5)(1)。 2. Scope 范围 2.1. This document provides information,guidance and recommendations to strengthen data integrity in support of productquality, safety and efficacy. The aim is to ensure compliance with r