WHO 数据完整性指南：良好的数据与记录规范.pdfVIP

WHO 数据完整性指南：良好的数据和记录规范 1. Introduction 介绍 1.1. Medicines regulatory systems worldwide have always depended upon the knowledge of organizations that develop, manufacture and package, test, distribute and monitor pharmaceutical products. Implicit in the assessment and review process is trust between the regulator and the regulated that the information submitted in dossiers and used in day-to-day decision-making is comprehensive, complete and reliable. The data on which these decisions are based should therefore be complete as well as being attributable, legible, contemporaneous, original and accurate, commonly referred to as “ALCOA”.世界范围的药品监管系统常常依赖 于企业在开发、生产和包装、检测、销售和监控药品方面的知识。在评估和审核过程中隐含 的是监管者和被监管者之间相信注册文件中提交的和用于日常决策的信息是全面、完整和可 信的。因此基于此做出决策的数据应该在完整的同时也要是可追溯至产生数据的人的、清晰 易读的、同步产生的、原始的和准确的。通常这个被称作 “ALCOA”。 1.2. These basic ALCOA principles and the related good practice expectations that assure data reliability are not new and much high- and mid-level normative guidance already exists. However, in recent years, the number of observations made regarding good data and record management practices (GDRP) during inspections of good manufacturing practice (GMP) (1), good clinical practice (GCP) and good laboratory practice (GLP) has been increasing. The reasons for the increasing concern of health authorities regarding data reliability are undoubtedly multifactorial and include increased regulatory awareness and concern regarding gaps between industry choices and appropriate and modern control strategies.这些基础的ALCOA 原则和保证数据可靠 性的相关良好的规范的期望都不是新的，许多高和中水平的规范性的指南已经存在了。尽管 如此，近几年，在GMP、GCP 和GLP 检查中出现与良好数据和记录管理规范相关的缺陷项 的数量还在增加。卫生监管机构对数据可靠性的越来越多的关注的原因毋庸置疑是多方面的 并包括增加的关于行业选择和适当的现代的控制策略之间的差距的法规意识和关注。 1.3. Contributing factors include failures by organizations to apply robust systems that inhibit data risks, to improve the detection of situations where data reliability may be compromised, and/or to investigate and address root causes when fai