FDA OOS指南2022年版-中英对照.pdf,Investigating Out- of- Specification (OOS) Test Results for Pharmaceutical Production Guidance for Industry 药品生产OOS调查行业指南 (2022年5月) 本文翻译仅供用于学习交流,请勿用于商用 文中翻译内容仅供参考,具体以英文原文
855-543-3784 或 301-796-3400;传真:301-431-6353 电子邮件:druginfo@ /drugs/guidance-compliance-regulatory-information/guidances-drugs 美国卫生与公众服务部 食品药品监督管理局 药物评价和研究中心(CDER) 2022 年 5 月 制药质量/生产标准 现行良好生产管理规范(CGMP) 本中文翻译由 DIRTRANS整理并提供,行业...
4th Floor马里兰州银泉,20993-0002电话:855-543-3784 或 301-796-3400;传真:301-431-6353电子邮件:druginfo@fda.hhs.govhttps://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs美国卫生与公众服务部食品和药品管理局药品评估和研究中心(CDER)2022 年 5 月药品质量/制造标准现行良好...
FDA Guidance Document: Investigating Out-of-Specification (OOS) Test Results For Pharmaceutical ProductionDrug Administration (FDA)
FDA化验室OOS指南中英文_Guidance_for_Industry_OOS_CHEN Contains Nonbinding Recommendations Guidance for Industry Investigating Out-of-Specification (OOS)Test Results for Pharmaceutical Production U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research...
Guidance for Industry Investigating Out of Specification (OOS) Test Results for Pharmaceutical Production DRAFT GUIDANCE This guidance document is being distributed for comment purposes only. Comments and suggestions regarding this draft document should be submitted within 60 days of publication of the ...
Contains Nonbinding Recommendations Guidance for Industry Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) October 2006 Pharmaceutical CGMPs Contains Non...
所有与OOS检测结果相关的记录均应封存。记录必须包括所有检验的完整数据以保证与已有质量标准相 符合。 C.FieldAlertReports Forthoseproductsthatarethesubjectofapprovedfullandabbreviatednewdrugapplications,regulations requiresubmittingwithin3workingdaysafieldalertreport(FAR)ofinformationconcerninganyfailureofa ...
今晚最后一个FDA资料，请大家笑纳！[Last edited by shich68 on 2006-7-17 at 23:03]
44、on12,Validation第12节:验证?Section18,SpecificGuidanceforAPIsManufacturedbyCellCulture/Fermentation第18节:采取细胞培养/发酵生产API的特殊指南Seealso7356.0002Mforadditionalinspectionguidanceonfermentation,extraction,andpurificationprocesses.也可以参考7356.0002关于发酵,提取和纯化工艺的附加检查指南。PACKAGINGANDLABELING...