事物调控.ppt

Slide * 永久制裁当然是永久的, 但是如果公司及时履行了制裁条例, 那么它有权向法院申请撤销制裁 “FDA Consent Decree” 如果一个药品公司反复违背CGMP相关规定, FDA将通过最高法院对其进行永久制裁 通常的惩罚手段包括罚款，赔偿政府在监管过程中的支出，限定时间采取措施解决存在问题, 还有对其诚信评估的降级 Regulatory Agency has Power to License the production of products for fixed duration Slide * Licenses issued on the basis of: Regulatory Information being submitted GMP inspections Recall product QP (Finished Dose) – Personally responsible for manufacturing stages No License – No sale Slide * Safe Drugs Pure Drugs Stable Drugs Labeled Correctly Effective Drugs GMP的目的 保证药品无污染 保证药品安全 这个意思是保证药品有正确的治疗范围 “…….individual managers of businesses conducting operations within the scope of the Act can be held criminally liable for actions of the business that are in violation of the act even though they did not personally engage in the illegal activity, did not instruct others to do so, and were not even aware of the illegal activity.” Slide * “Executive Liability”行政责任 FD C Act states 这个可以忽略 Management with Executive Responsibility means “那些有能力在生产中建立或完善质量监管机制的高级雇工有义务对该机制进行完善，以提高药品安全性 Slide * “主管负责人职责” 这意味着每个公司的主要负责人有行政责任来确保 该公司拥有健全的质量管理机制并在各级生产部门 中使用 “The Act imposes not only a positive duty to seek out and remedy violations when they occur but also and primarily a duty to implement measures that will insure that violations will not occur” Slide * “最高法院解释权” US Supreme Court in the case of United States vs. Park (1975) ruled: 可忽略 Slide * “Employees Responsibilities” Procedures Records Equipment GMP Awareness 由于药品的特殊性（关乎人命）所以药业员工有义务在工作时做到以下几点 留有工作录像 具备GMP知识 保证穿戴工作服 遵守规章制度 Slide * “The Goal of GMP” Protect the Consumer GMP是保护消费者的条例，我终于蛋疼的翻译完了 Regulatory bodies such as the FDA and its European equivalent, the EMEA #, require companies to investigate OOS test results and document the findings. # Failure to investigate OOS results is not acceptable. Even if a batch is rejected based on an OOS result, an investigation is still required to discover: Dr Ed Carey Slide * 在19世纪，那时很多药品都被毫无根据的夸大了疗效（右图这个药的大概意思就是吃