e) Written procedures for filter integrity testing (b)(4) of (b)(4) um filters for (b)(4) are not adequate in that it allows re-testing of the (b)(4) filters up to (b)(4) times with different (b)(4) soluti...
Inadequate OOs investigations,OOs调查不充分 Inadequate CAPAs,CAPA(Corrective action and preventive action) 纠正措施和预防措施不充分 某一份相关的警告信如下: 某一家公司忽视了之前所有不合格的检测结果,并且没有提供充分的科学理由来证明原始OOS无效或确定根本原因。相反,该公司用无效和未经验证的测试方法重新取样...
Out of Specification investigations do not contain supporting documents, statements or interviews with analysts or laboratory technicians to support human error, corrective or preventative actions, appropriate root cause analyses, or review for product impact. OOS调查不包含支持文件、声明或与分析师或实验室...
Out-of-specification (OOS) investigations are not normally needed for in-process tests that are performed for the purpose of monitoring and/or adjusting the process. 生产操作中的正常监控过程和工艺调节过程中出现的超出标准的偏差(OOS),通常情况不需要调查。 Blending Batches of Intermediates or APIs ...
studies, manufacturing experience, demonstrated process capability, out-of-specification 192 (OOS) investigations, and stability data with the particular product and process, and in some cases 193 manufacturing information with similar products or processes (e.g., for some monoclonal antibody 194 ...
若要判定检测结果无效并不考虑作为批次符合性标准的判定,必须有一个有效的、有据可查的、科学合理上的理由(见参见§§8 211.160(b)、第211 188、211. 192 和 212.71(b)和《FDA行业指南:OOS调查》。即使检验结果在科学合理调查的基础上被判定为无效, 提供给质量部门的完整CGMP批记录仍需要包含初始的 (无效) ...
若要判定检测结果无效并不考虑作为批次符合性标准的判定,必须有一个有效的、有据可查的、科学合理上的理由(见参见§§8 211.160(b)、第211 188、211. 192 和 212.71(b)和《FDA行业指南:OOS调查》。即使检验结果在科学合理调查的基础上被判定为无效, 提供给质量部门的完整CGMP批记录仍需要包含初始的 (无效) ...
23、RE(OUT-OF-SPECIFICATION)LABORATORYRESULTS Evaluatethecompanyssystemtoinvestigatelaboratorytestfailures.These investigationsrepresentakeyissueindecidingwhetheraproductmaybe releasedorrejectedandformthebasisforretesting,andresampling. Inarecentcourtdecisionthejudgeusedthetermout-of-specification (OOS) 24、laboratoryres...
“(g) New drug products for investigational use are exempt from the requirements of this section, provided that they meet appropriate standards or specifications as demonstrated by stability studies during their use in clinical investigations. Where new drug products for investigational use are to be ...
A comprehensive independent assessment of your overall system for investigations of deviations, atypical events, complaints, OOS results, and failures. Your CAPA should include, but not be limited to, improvements in investigation competencies, root cause analysis, written procedures, and quality unit ov...