药品监督抽验中医院制剂不合格项目的质量分析

• 作 者: 孙秋英 陈连珊
• 机 构: 北京市宣武区药品检验所,北京市药品监督管理局宣武分局 100055,100055
• 出 处: 首都医药
• 发表日期: 2003年06期
• 关键词: 药品监督抽验 不合格项目 药品经营企业 药品检验所 质量分析 法定要求 塑料瓶装 装量差异 药品质量 药品管理法

2002年度是执行新药品管理法的第一年,依据法定要求,北京市宣武区药品检验所对药品经营企业、医疗机构共收检品503批次,不合格5批次,不合格率为1％。其中医院制剂98批次,不合格4批次,不合格率为4.08％。 对医疗机构报备制剂抽验率达30％,而医院常用制剂约占报备制剂的30％,实际抽检医院制剂品种约占常用品种100％。

2002 is the first year to implement the new drug administration law. According to statutory requirements, a total of 503 batches of goods and 5 failed batches were obtained from the drug control enterprises and medical institutions in Xuanwu District, Beijing. The unqualified rate was 1 %. Of which 98 batches of hospital preparations, four batches failed, the failure rate of 4.08%. The rate of 30% for the preparation of preparations for medical institutions is reported, while the commonly used preparations for hospitals account for about 30% of the preparation for preparation. The actual varieties of preparations for hospital sampling account for about 100% of the commonly used varieties.