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 . . . . . . . . . . ...
