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of Injectable Products for Visible Particulates Guidance for Industry(Draft Guidance),以下简称FDA指南草案],系统阐述了基于风险评估与生命周期管理的整体可见异物检查和控制策略,同时提出应在严格确保注射剂生产符合《药品生产质量管理规...
Visibleparticulates in injectable products can jeopardize patient safety. Thisguidance addresses the development and implementation of a holistic, risk-basedapproach to visible particulate control that incorporates product development,manufacturing controls, visual inspection techniques, particulate identification,...
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 processing at fda.gov/media/71026/dow.有关无菌处理的...
FDA行业指南:注射产品可见颗粒的检查-202112草案(中英文对照版).pdf,FDA 行业指南:注射产品中可见颗粒的检查-2021 草案 Inspection of Injectable Products for Visible Particulates 注射产品中可见颗粒的检查 Guidance for Industry 行业指南 DRAFT GUIDANCE This gui
You found recurrent contamination of your sterile injectable drug products with foreign particulate matter, but you failed to adequately investigate and identify the root causes of the recurrent contamination. 你们发现你们的无菌注射药品反复受到异物污染,但你们未能充分调查和确定反复污染的根本原因。
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of Injectable Products for Visible Particulates Guidance for Industry(Draft Guidance),以下简称FDA指南草案],系统阐述了基于风险评估与生命周期管理的整体可见异物检查和控制策略,同时提出应在严格确保注射剂生产符合《药品生产质量管理...
Your firm manufactures (b)(4) sterile injectables and solid dosage drug products. You failed to conduct adequate out-of-specification (OOS) and complaint investigations, including the identification of the root cause and timely implementation of...
Visibleparticulates in injectable products can jeopardize patient safety. Thisguidance addresses the development and implementation of a holistic, risk-basedapproach to visible particulate control that incorporates product development,manufacturing controls, visual inspection techniques, particulate identification,inve...
Visibleparticulates in injectable products can jeopardize patient safety. Thisguidance addresses the development and implementation of a holistic, risk-basedapproach to visible particulate control that incorporates product development,manufacturing controls, visual inspection techniques, particulate identification,inve...
The sterilization and aseptic processing of sterile APIs are not covered by this guidance, but should be performed in accordance with GMP guidances for drug (medicinal) products as defined by local authorities. 本文件适用于人用药品(医疗用品)所含原料药的生产。它适用于无菌原料药在灭菌前的步 骤。