Your firm failed to establish adequate written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or represented to possess. 贵公司未能建立充分的生产和工艺控制书面程序,以确保药品具有声称或声...
2.4、变更没有得到有效控制,针对变更没有进行充分的评估,甚至关键的工艺变更没有进行验证。 FDA相关警告信举例:Primarydeviations: no adequate production and process controls, inadequate changecontrol, no performance verification after the change, missing recor...
4.Failed to establish adequate written procedures for production and process controls designed . 未能建立足够的生产和过程控制书面程序 4.1.Failed to provide adequate challenge test set vials 未能提供足够的挑战测试集小瓶 4.2.Quality unit personnel have not maintained a defect library for training purposes...
5. Your firm failed to establish adequate written procedures for production and process control designed to assure that the drug products you manufacture have the identity, strength, quality, and purity they purport or are represented to possess (21CFR 211.100(a)). 贵公司未能建立足够的书面生产和...
8. PRODUCTION AND IN-PROCESS CONTROLS 生产和过程控制 8.1 Production Operations 生产操作 8.2 Time Limits 时限 8.3 In-process Sampling and Controls 工序取样和控制 8.4 Blending Batches of Intermediates or APIs 中间体或原料药的混批 8.5 Contamination Control 污染控制 9. PACKAGING AND IDENTIFICATION LABELING...
Your firm failed to establish adequate written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or represented to possess.贵公司未能建立充分的生产和工艺控制书面程序,以确保药品具有声称或声称...
PRODUCTION AND IN-PROCESS CONTROLS 生产和过程控制 Production Operations 生产操作 Time Limits 时限 In-process Sampling and Controls 工序取样和控制 Blending Batches of Intermediates or APIs 中间体或原料药的混批 Contamination Control 污染控制 9. PACKAGING AND IDENTIFICATION LABELING OF APIs AND INTERMEDIATES...
MATERIALS MANAGEMENT 物料管理7.1 General Controls 控制通则7.2 Receipt and Quarantine 接收和待验7.3 Sampling and Testing of Incoming Production Materials 进厂物料的取样与测试7.4 6、 Storage 储存7.5 Re-evaluation 复验8. PRODUCTION AND IN-PROCESS CONTROLS 生产和过程控制8.1 Production Operations 生产操作8.2...
8. 参考 21 CFR 211 subpart F, Production and Process Controls for related regulations. 9. 见guidance for industry ICH Q8 (R2) Pharmaceutical Development (November 2009) 中对控制策略的定义 10. PAT工具详见guidance for industry PAT – A Framework for Innovative Pharmaceutical Development, Manufacturin...
"There shall be written procedures for production and process control designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess." -8- Several sections of the CGMP regulations state validation requirements in more specific ...