行业指南：药检品测结果OOS调查指南.docVIP

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for Industry， Investigating Out of Specification (OOS) Test Results for Pharmaceutical Production 行业指南： 药品检验结果OOS的调查 DRAFT GUIDANCE 指南草案 U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) September 1998 CP # TABLE OF CONTENTS目录 I. INTRODUCTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . . . . . . . . .. . . . .. . . .. . . 1 II. BACKGROUND . 背景. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ... . . . . . . 1 III. IDE