SOP-Q01016[1].04 检验结果超标（OOS）调查程序 （联邦）.pdfVIP

文件名 检验结果超标（OOS）调查程序 文件编 SOP-Q01016.04 称 号 Name Procedure for the Investigation of Outof Specification Results No. 起草人/ 日期 审核人/ 日期 批准人/ 日期 执行日期 Drafted By/Date Checked By/Date Approved By/Date Effective Date 1 目的 规定对超出标准的检验结果进行调查的程序。 Purpose To define the process for conducting investigations of out-of-specification (OOS) test results. 2 范围 适用于原辅料、包装材料、回收溶媒、工艺用水、中间体、成品及稳定性试验的 检验数据超过质量标准规定的情况。 Scope OOS test results for raw and auxiliary materials, packing materials, recycle solvents ， process water, intermediates, products and products’ stability. 3 责任 Responsibility 原辅料、包装材料、回收溶媒、工艺用水、工艺用气(洁净压缩空气/氮气)、环境监测 等检测结果超出现行质量标准，填写OOS 调查报告，如非实验室原因，发不合格报告书， 交QA 处理。该类OOS 调查报告，由QC 归档备查。 With respect to OOS test results for raw and auxiliary materials, packing materials, recycle solvents ，process water, process gas (compressed air/ nitrogen), and circumstance monitoring, OOS reports should be filled. If OOS results are due to non-laboratory reasons, COAs should be sent to QA for further investigation. The OOS reports should be filed on request. 成品、中间体、稳定性样品检验结果超过标准，遵循OOS 内/外调查，调查报告交QA 归档。 With respect to OOS test results for intermediates, products and stability tests, fill the OOS report as per the following OOS descriptions, and then send the reports to QA for investigation and filing. OOS 涉及到的相关人员：化验员（QC）、监督员（QA）、化验室主管 （QC）、QC 负责人、 质量管理部经理（QA）、生产车间及设备部。 Relevant personnel involved in OOS: Analyst (QC), supervisor (QA), laboratory supervisor (QC), QC supervisor, QA manager (QA), workshop and equipment department. 4 定义Definitions 4.1 超标检验结果：即所有超出药物申请、药物主文件、药典质量标准或企业内控标准的化 学检验结果。包括系统适应性结果。 OOS res