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.
作者
张小莉
ZHANG Xiaoli(Xianyang Center for Food and Drug Control,Xianyang,Shaanxi,China 712000)
出处
《中国药业》
CAS
2019年第8期79-81,共3页
China Pharmaceuticals
关键词
药品
微生物限度检查方法
适用性
药品监管
drug
microbial limit test method
applicability of method
drug administration
