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DRAFT GUIDANCE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. IDENTIFYING AND ASSESSING OOS TEST RESULTS  检验结果的判断和评估. . .. 2
Responsibility of the Analyst 检验的责任.        . . . .. 2
B. Responsibilities of the Supervisor的责任.   . .   . . . . .3
IV. INVESTIGATING OOS TEST RESULTS   检验结果的调查.   . . . .  . 5
A. General Investigational Principles . .   一般调查原则.       . . . 5
B. Laboratory Phase of an Investigation . 实验室的调查    .. . . ..   . 6
V. CONCLUDING THE INVESTIGATION . .调查结论     . . ..  . 10
A. Interpretation of Investigation Results . 调查结果的解释       . . 10
B. Reporting . . .报告      . . . ..       . . . . 11
This guidance has been prepared by the Office of Compliance/Division of Manufacturing and Product 
Quality, Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration. This guidance document represents the Agency’s current thinking on evaluating OOS test results. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute, regulations, or both.
本指南由FDA的CDER的达标办公室制造、产品、质量分部起草，本指南阐明了机构关于评估OOS检验结果的现行的想法。它不会创造或赠与任何人任何权力，也不会约束FDA或公众。如果其他可选择的相接近的指南能满足适用的法令和法规的要求，也可以使用。
GUIDANCE FOR INDUSTRY1
Investigating Out of Specification (OOS) Test Results
for Pharmaceutical Production
I. INTRODUCTION 
序言
This guidance for industry provides the Agency’s current thinking on how to evaluate suspect, or out of specification (OOS), test results. For purposes of this document, the term OOS results includes all suspect results that fall outside the specifications or acceptance criteria established in new drug applications, official compendia, or by the manufacturer.
本行业指南反应了FDA关于如何评估怀疑的或OOS检验结果的现行想法，本指南的目的，OOS结果包括超出了新药申请材料、、生产商建立的可接受标准或规格的的结果。
This guidance applies to laboratory testing during the manufacture of active pharmaceutical ingredients, excipients, and other components and the testing of finished products to the extent that current good man
行业指南：药品检测结果OOS调查指南.doc