Quality System Information for Certain Premarket Application Reviews; Guidance for Industry and FDA Staff (上市前申请评估的质量体系信息;行业指南和FDA工作人员指导) 设计控制 Design Control Guidance For Medical Device Manufacturers (医疗器械生产设计控制指南) 人为因素 Human Factors and Medical Devices (人为因...
Some medical device manufacturers with foreign QMS certifications (such as ISO 13485) can submit their device applications before completing the B-GMP inspection. To qualify for this exception, you must submit through a member of ABIMED (Emergo is a member) and you must submit proof that you ...
Training methods must be periodically reviewed so that manufacturers know they remain effective in keeping workers properly competent in what they do. Effective training and knowledge sharing can be powered by an eQMS that is a single source of truth for your entire organisation. 3. Maintain your ...
1. Request to manufacturers to conduct risk assessments to evaluate the potential for the presence of nitrosamine impurities WHO药品预认证部门要求生产商执行亚硝胺杂质风险评估 发布时间:2020/04/02 原文链接:https://extranet.who.int/prequal/news/manufacturers-conduct-risk-assessments-impurities 2. Good ...
1. Medical devices — Post-market surveillance for manufacturers 医疗器械上市后监督指南 发布时间:2020/07/20 IMDRF 1. IMDRF/AE WG/N43 FINAL:2020 Updated Annexes (Edition 4.1) 更新医疗器械不良反应报告分类的术语 发布时间:2020/07/27
附属器械(accessory device)在联邦规章典集第21篇第807部和《器械制造商的企业注册与器械列表》(Establishment Registration and Device Listing for Manufacturers of Devices)中已讨论。这些器械,如血液透析试管或X射线诊断部件,以健康相关的目的,单独地包装、标识并销售给医院、医师等,经常被错误地当作部件。然而,FDA把...
第第PAGE 1 页共 NUMPAGES 48 页新版的药品GMP指南GUIDE TO GOOD MANUFACTURING PRACTICE FORMEDICINAL PRODUCTS 药品GMP指南第一部分 GUIDE TO GOOD MANUFACTURING PRACTICE FORMEDICINAL PRODUCTSPART I PE 009-15 (Part I) 1 May 2021 ? CHAPTER 1 - PHARMACEUTICAL QUALITY SYSTEM 第一章药品质量体系 ?
2. Food manufacturers have implemented GMP standards to prevent any contamination in their production lines. 食品制造商已实施GMP标准,以防止生产线上的任何污染。 3. The medical device industry must comply with GMP regulations to ensure the safety of the products used by patients. 医疗器械行业必须遵守...
Medical equipmentInspectionStatistical analysisAuditingRequirementsA statistical analysis was performed of the results of the first 844 Good Manufacturing Practice inspections of device manufacturers. It was found that the Quality Audit Worksheet could be greatly condensed by eliminating some requirements that ...
Enforcement Regulation of the Decree on Standards for Facilities of Medicinal Product Manufacturers and...