中英文_ICH-Q8,Q9,Q10.ppt

PQS Management Responsibilities Expectations PQS管理职责与期望 Active sponsorship and communication across organization 积极发起和进行跨组织沟通 Establish quality policy 建立质量方针 Ensure quality is an attribute and not jut a function 保证质量是一个属性，而不仅仅是一个功能 Allocate resources and ensure PQS is appropriately prioritized 分配资源，并确保PQS得到适当优先 Active involvement in QSMR and other reviews 积极参与QSMR（质量体系管理审评）和其他审查 Establishing clear roles responsibilities 建立明确的角色和责任 Advocate continual improvement 倡导持续改进 * ICH Q8, Q9, Q10人用药物注册技术要求国际协调会议 Brenda Uratani, Ph.D. Assistant Country Director (Drugs) FDA China Office, Beijing * History of Pharmaceutical Quality Management药品质量管理的历史 1960’s and before: Reliant solely on quality control 20世纪60年代以前：仅仅依靠质量控制 Focused on the Product Specification 专注于产品质量标准 Defect detection by end product testing 通过最终产品测试来检测缺陷 Advantage 优势 Sometimes detects defects 有时能检测出缺陷 Disadvantage 劣势 Faults found too late 故障发现为时已晚 Often fails 经常失败 High cost 成本高 * History of Pharmaceutical Quality Management药品质量管理的历史 Early 1970’s: added quality assurance GMP 20世纪70年代早期：增加了质量保证和 GMP Written procedures 书面规程 Focus on production process 侧重于生产过程 Defect prevention using process controls 通过过程控制来预防缺陷 Advantages 优势 Documented systems 书面记录的系统 Improved quality 提高了质量 * A New Approach to Regulation一种新的监管方法 U.S. FDA 21st Century GMP initiatives 美国FDA 21世纪GMP动议 Process analytical technology (PAT) 过程分析技术 (PAT) Process understanding 过程的理解 Control in-process rather than end-product testing 对过程进行控制，而非对最终产品进行检测 Minimize risks of poor quality 质量低劣风险最小化 Identify the parameters that are critical to product quality 确定对产品质量关键的参数 Measure these parameters 测量这些参数 Control these parameters (feed back, feed forward) 控制这些参数（反馈、前馈） * Pharmaceutical Quality System药品质量体系 * ICH Q8, Q9, Q10 A harmonized pharmaceutical quality system applicable across the life cycle of the product emphasizing an integrated appro