药用包装材料监督抽验情况及探讨

目的 对药包材监督管理工作提出建议,以更好地发挥药包材监管作用,提高药包材质量.方法 采用每年考察同一类药包材品种抽样法,在2003～2008年间,湖南省医疗器械和药用包装材料(容器)检测所对全省各药包材生产企业和使用单位累计抽样检测173批药包材产品,检验结果显示,本省药包材产品检验不合格率和检验不合格项目逐年减少.结果与结论 药包材的监督抽验是有效的监管手段,是药包材行业的发展、监管的需要,对提高药包材整体质量有促进作用.

Analysis and Discussion on Sample Testing of Pharmaceutical Packaging Material

Objective To provide suggestions for the supervision of pharmaceutical packaging materials, so as to improve the supervision and promote the drug packaging quality. Methods During 2003 to 2008, by the sampling method for one category in each year, 173 batches of pharmaceutical packaging material products from Hunan province were inspected by Hunan Testing Institute for Medical Devices and Pharmaceutical Packaging Materials. The test results showed that the disqualification rate of products and items were is necessary promote the decreased year by year. Results and Conclusion Sampling inspection is an effective way and also for the development and supervision of pharmaceutical packaging material products, which can quality of pharmaceutical packaging material products.