B. Quality Guidelines(质量指南) C. Quality Control(质量控制) D. Quality Management(质量管理) 查看完整题目与答案 ICH Q7 适用于以下哪些原料药? A. 化学合成原料药 B. 生物技术原料药 C. 天然药物原料药 D. 以上都是 查看完整题目与答案 质量管理体系的核心是 A. 质量方针和质量...
guidelines-focused approach to total quality management (TQM), or they'll struggle to adapt when the next set of cGMP is released, or any other issue occurs which requires organizational change.
cGMP guidelines for specific applications can be found in various documents. Whether it is 21CFR211 for finished pharmaceuticals, ICH Q7 for APIs, International Pharmaceutical Excipients Council (IPEC) Guide for excipients, 21CFR110 for food application or the FDA's Inspection Operations Manual f...