事物调控.pptVIP

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