关于药品检验结果OOS的调查VIP专享VIP免费

Guidance for Industry，Investigating Out of Specification(OOS) Test Results for Pharmaceutical Production行业指南：药品检验结果 OOS 的调查DRAFT GUIDANCE指南草案U.S. Department of Health and Human ServicesFood and Drug AdministrationCenter for Drug Evaluation and Research (CDER)September 1998CP #TABLE OF CONTENTS 目录I. INTRODUCTION 序言. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . . . . . . . . .. . . . .. . . .. . . 1II. BACKGROUND . 背景. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ... . . . . . . 1III. IDENTIFYING AND ASSESSING OOS TEST RESULTS OOS 检验结果的判断和评估. . .. 2A.Responsibility of the Analyst 检验员的责任. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 2B. Responsibilities of the Supervisor 主管的责任. . . . . . . . . . . . . . . .. . . . . .. . . . . . . . . . . . . . . .. . . . .3IV. INVESTIGATING OOS TEST RESULTS OOS 检验结果的调查. . . . . . . . . . . . . . . . . . . .. 5A. General Investigational Principles . . 一般调查原则. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5B. Laboratory Phase of an Investigation . 实验室的调查阶段 . . . . . . . . . . . . . . . .. . . .. . . . . . . . . . . . 6V. CONCLUDING THE INVESTIGATION . .调查结论 . . . . . . . . . . . . . . . . . . . . . . . . .. . .. . . . . . . 10A. Interpretation of Investigation Results . 调查结果的解释 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10B. Reporting . . .报告 . . . . . . . . . . ...