药品微生物限度检查方法适用性资料问题分析
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摘要
目的促进企业提供的药品微生物限度检查方法适用性资料信息的准确、完整、规范。方法收集从不同企业索取的药品微生物限度检查方法适用性资料,分析存在的问题。结果主要问题有资料内容不符合标准、企业人员自身职业素质待改进。结论药品生产企业应提高人员职业道德素质和业务检验能力。建议有关部门规范资料格式,并将处方、工艺简单的制剂微生物限度检查方法收集成册,或生产企业将每个品种的检查方法资料上传到网上并及时更新。
Objective To promote the accuracy, completeness and standardization of information on the applicability of drug microbial limit test methods provided by enterprises. Methods Data on the applicability of microbial limit test methods for drugs from different manufacturers were collected and the existing problems were analyzed. Results The main problems were as follows: the data content didn't meet the standards and the professional quality of the staff in the enterprises needed to be improved. Conclusion Pharmaceutical manufacturing enterprises should improve the professional ethics and inspection ability of the staff. It is suggested that the relevant departments standardize the data format and collect the microbial limit test methods of simple formulations and processes into a book,or the manufacturing enterprises upload the inspection method data of each variety to the internet and update them in time.
Objective To promote the accuracy, completeness and standardization of information on the applicability of drug microbial limit test methods provided by enterprises. Methods Data on the applicability of microbial limit test methods for drugs from different manufacturers were collected and the existing problems were analyzed. Results The main problems were as follows: the data content didn't meet the standards and the professional quality of the staff in the enterprises needed to be improved. Conclusion Pharmaceutical manufacturing enterprises should improve the professional ethics and inspection ability of the staff. It is suggested that the relevant departments standardize the data format and collect the microbial limit test methods of simple formulations and processes into a book,or the manufacturing enterprises upload the inspection method data of each variety to the internet and update them in time.
引文
[1]国家药典委员会.中华人民共和国药典(一部)[M].北京:化学工业出版社,2005:71-72.
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[9]张小莉.药品微生物限度检查误差的影响因素及控制方法[J].中国药业,2018,27(6):90-92.
[10]杨立,陈历刚.影响微生物限度检查及方法验证的影响因素[J].医药卫生,2016,2(6):125.
[11]李佳宁.影响微生物限度检查方法验证结果的若干因素分析[J].中国药业,2007,16(9):35-36.
[12]徐秀丽.药品微生物限度检查方法及方法适用性[J].中国科学技术概览,2018(7):223.
[13]张红霞,李加恒.浅谈微生物限度检查方法适用性资料的规范性[J].中国卫生标准管理,2018,9(8):115-117.
[14]吴潇.近年来我国药品微生物限度检查方法验证概况[J].中国现代药物应用,2008,2(20):115-116.
[2]薛坤.我国微生物限度检查方法验证研究概况[J].中国城乡企业卫生,2008(2):91-93.
[3]杨晓莉,李辉,马英英,等.中国药典2015版非无菌产品微生物限度检查:微生物计数法[J].药物分析杂志,2016,36(6):1101-1107.
[4]国家药典委员会.中华人民共和国药典(四部)[M].北京:中国医药科技出版社,2015:145-149.
[5]乐永正,杨晓淑.药品微生物限度检查现状与分析[J].今日药学,2009,19(2):63-66.
[6]罗书香.药品微生物限度检查验证资料分析[J].中国药事,2007,21(7):525-526.
[7]赵建英,寿文虹,李爱玲.加强药品无菌检查和微生物限度检查方法验证的对策[J].中国药业,2008,17(8):6.
[8]张伟,李波,罗国安.中国药典分析检测技术指南[M].北京:中国医药科技出版社,2017:568-569.
[9]张小莉.药品微生物限度检查误差的影响因素及控制方法[J].中国药业,2018,27(6):90-92.
[10]杨立,陈历刚.影响微生物限度检查及方法验证的影响因素[J].医药卫生,2016,2(6):125.
[11]李佳宁.影响微生物限度检查方法验证结果的若干因素分析[J].中国药业,2007,16(9):35-36.
[12]徐秀丽.药品微生物限度检查方法及方法适用性[J].中国科学技术概览,2018(7):223.
[13]张红霞,李加恒.浅谈微生物限度检查方法适用性资料的规范性[J].中国卫生标准管理,2018,9(8):115-117.
[14]吴潇.近年来我国药品微生物限度检查方法验证概况[J].中国现代药物应用,2008,2(20):115-116.