摘要
引入药品质量风险管理(ICHQ9)理念,尝试建立口服固体制剂生产质量风险评价系统。确定了含量偏离、含量波动等8个风险因素,通过对多批次药品风险因素的考察来计算各企业药品生产风险因子,并进行风险优先数的排列。以此反映药品生产企业工艺稳定性,发掘药品生产过程的潜在风险,旨在前瞻性地发现药品生产环节的隐患,最大程度避免药害事件的发生。
This paper introduces the quality risk management （ICH Q9） concept and tries to establish risk assessment system. Eight risk factors are defined including content deviation and content fluctuation. After the study of risk factors in many batches of drugs, the risk figures of every pharmaceutical factory are calculated, and the risk priority numbers are arranged, which reflect the technical stability of pharmaceutical enterprises. This paper aims to discover predictably the potential risks in manufacturing process so as to minimize the adverse drug events.
出处
《现代药物与临床》
CAS
2010年第4期304-307,共4页
Drugs & Clinic
关键词
口服固体制剂
药品安全
生产质量
风险评价
风险因子
oral solid dosage
drug safety
manufacturing quality
risk evaluation
risk figure
