FDA 发布药品生产中超标（OOS）检验结果调查指南最终版第 2 级修订
Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production
FDA 药品评价与研究中心（CDER）发布《药品生产中超标（OOS）检验结果调查》指南最终版第 2 级修订，文件编号 FDA-1998-D-0019。该指南说明 FDA 对如何评估 OOS 检验结果的当前思路，OOS 结果包括超出药品申请、DMF、官方药典或企业既定标准与接受标准的检验结果，也适用于超出既定标准的在控实验室检验。
文件界定 OOS 结果涵盖申请、DMF、药典与企业标准之外的检验结果，也涉及在控实验室检验，可用于比对实验室调查的范围。
GUIDANCE DOCUMENT
Final Level 2 Revised Guidance
- Docket Number:
- FDA-1998-D-0019
- Issued by:
-
Guidance Issuing Office
Center for Drug Evaluation and Research
This guidance for industry provides the Agency’s current thinking on how to evaluate out-of- specification (OOS) test results. For purposes of this document, the term OOS results includes all test results that fall outside the specifications or acceptance criteria established in drug applications, drug master files (DMFs), official compendia, or by the manufacturer. The term also applies to all in-process laboratory tests that are outside of established specifications.
Submit Comments
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-1998-D-0019.
来源：FDA Pharmaceutical Quality Documents · fda.gov