新增及修订的条款翻译如下: PE 009-14 PIC/S GMP GUIDE PIC/S GMP 指南 CHAPTER 3 PREMISES AND EQUIPMENT 第三章 厂房设施和设备 Production Areas 生产区 3.6 Cross-contamination should be prevented for all products by appropriate design and operation of manufacturing facilities. The measures to prevent...
use for the equipment's operation, and are free to modify standard equipment designs to best suit their process and that are compatible with the product under process. The CGMPs require that equipment be of appropriate design to facilitate operations for its ...
Scope 范围 Principle 原则 Part A: General guidance A部分:一般指南 Supplimentary provisions to PIC/S GMP Guide Part I PIC/S GMP指南第一部分的补充规定 Chapter 1 Pharmaceutical quality system 章节1?药品质量体系 Chapter 2 Personnel 章节2?人员 Chapter 3 Premises and equipment 章节3 ?设备设施 ...
Design of both the plant and processes. 工厂与工艺设计 ii. Premises and equipment. 设施与设备 iv. Personnel. 人员 v. Utilities. EU GMP 附录 1 无菌药品生产 草案 译文仅供参考 翻译:JULIA 页 3/70 EU GMP Annex 1 : Manufacture of Sterile Products DRAFT 公用设施 vi. Raw material controls – ...
Direct intervention (e.g. without the protection of barrier and glove port technology) into the grade A area by operators should be minimized by premises, equipment, process and procedural design. A 级:高风险操作的关键区域(例如无菌加工线、灌装区、塞碗、开放式初级包装或在第一空气保护下进 行...
Facility, equipment and process design must should be optimized, qualified and validated according to Annex 11 and Annex15the relevant sections of EU the Good Manufacturing Practices (GMP) guide. The use of appropriate current technologies (e.g. Restricted Access Barriers Systems (RABS), isolators,...
特定培训知识和技能要求指南,还有人员资质确认指南 5.Premises 设施 Generalguidanceregardingthespecificneedsforpremisesdesignandalsoguidanceon thequalificationofpremisesincludingtheuseofbarriertechnology. 关于设施设计的特定需求通用指南,以及设施确认包括隔离技术应用的指南 6.Equipment 设备 Generalguidanceonthedesignand...
43. Clarification of Radiation Control Regulations For Manufacturers of Diagnostic X-Ray Equipment 针对诊断 X 射线设备制造商的辐射控制法规 发布时间:2024/09/27 44. Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations Questions and Answers ...
EU-GMP-Part-II-Annexes-15.pdf EUROPEAN COMMISSION ENTERPRISE DIRECTORATE-GENERAL Single market, regulatory environment, industries under vertical legislation Pharmaceuticals and cosmetics Brussels, July 2001 Working Party on Control of Medicines and Inspections Final Version of Annex 15 to the EU Guide to...
欧盟GMP附录一 无菌产品生产 2020版_中英文对照版_