o通过这些和其他补救措施修订OOS调查程序 For more information about handling failing, OOS, out-of-trend, or other unexpected results and documentation of your investigations, see FDA’s guidance document Investigating Out-of-Specification (OOS) Tes...
The high percentage of rejected ampules and particulates found in cleared ampules after 100% visual inspection indicate that you may have released drug product that contains particulates.你们的药品质量缺乏保证。例如,在 100% 目视检查后的质量保证审核中,发现了前面批放行 100% 目视检查未发现的其他颗粒...
一、Test(s) performed You should identify the tests performed. If the testing was conducted as recommended by a FDA guidance document or FDA-recognized consensus standard. we recommend that you state such in the test report summary. 说明已执行的测试是否是按照FDA指导文件或FDA认可的共识标准进行检测...
生产线保护有限,高度暴露于手动干预和周围空气的污染风险。 For additional guidance on aseptic processing see FDA’s guidance document Sterile Drug Products Produced by Aseptic Processing—Current Good Manufacturing Practice to help you meet the CGMP requirements when manufacturing sterile drugs using aseptic ...
Your production manager repeatedly accessed and printed uncontrolled blank copies of production records, media fill records, visual inspection records, process validation batch records, and cleaning validation records saved on his computer or through your docume...
Your production manager repeatedly accessed and printed uncontrolled blank copies of production records, media fill records, visual inspection records, process validation batch records, and cleaning validation records saved on his computer or through your document management system. When production employees ...
outlying and anomalous results). Note that a justification for methods and/or acceptance criteria is generally not needed if they were directly obtained from a FDA-recognized consensus standard or guidance document. A discussion of the test methods or acceptance criteria, if needed, can include how...
Guidance for Industry ⾏业指南 TABLE OFCONTENTS ⽬录 I. INTRODUCTION 介绍 II. STATUTORY AND REGULATORY FRAMEWORK 法律法规框架 III. CLINICAL RISK OF VISIBLE PARTICULATES 可见颗粒物的临床风险 IV. QUALITY RISK ASSESSMENT 质量风险评估 V. VISUAL INSPECTION PROGRAM CONSIDERATIONS ⽬视检查的程序...
美国FDA于2021年12月发布了《注射剂可见异物检查行业指南(草案)》[15][Inspection of Injectable Products for Visible Particulates Guidance for Industry(Draft Guidance),以下简称FDA指南草案],系统阐述了基于风险评估与生命周期管理的整体可见异物检查和控制策略,同时提出应在严格确保注射剂生产符合《药品生产质量管理...
This guidance addresses the development and implementation of a holistic, risk-based approach to visible particulate control that incorporates product development, manufacturing controls, visual inspection techniques, particulate identification, investigation, and corrective actions designed to assess, correct, ...