PDA TR80-2018（中英文）《制药实验室数据完整性管理体系》.pdf

Technical Report No. 80 技术报告 No.80 Data Integrity Management System for Pharmaceutical Laboratorie 制药实验室数据完整性管理体系 翻译：旦霆科技 张、炒年 、椒陵小小兵、科学的 mushroom、米田小鱼、Skyla Sun、THE ★ ONE、 tingting、Sword、逐＜梦》、流浪的沙子 校对：Sword、炒年 、流浪的沙子、Owen GMP 办公室 • 专业的 GMP 合规性研究组织 • 国内外 （FDA、 EMA、 MHRA、 CFDA、 WHO 、 PIC/S 等） GMP 法规解读； • 国内外制药行业 GMP 监管动态； • GMP 技术指南 （ISPE、 PDA、 ISO、 ASTM 等）分享 官方微信公众号： PDA TR 80 制药实验室数据完整性管理体系 1 / 98 GMP 办公室翻译组 1.0 Introduction 1.0 简介 A primary responsibility of pharmaceutical manufacturers is to provide safe and efficacious products of appropriate quality to patients and consumers by assuring decisions are based on accurate, reliable, truthful, and complete data. Data integrity is a mandatory requirement and key concern of health authorities. At the time of this writing, data integrity citations, especially those related to computerized systems in laboratory and manufacturing environments, have resulted in a number of significant, well­publicized enforcement actions from the U.S. Food and Drug Administration (FDA) and other regulatory authorities, including the United Kingdom Medicines and Healthcare products Regulato