Analysis of the Results of Drug Sampling and Testing in Hubei Province from 2013 to 2015
10.6039/j.issn.1001-0408.2017.01.33
- VernacularTitle:2013-2015年湖北省药品质量监督抽验结果分析
- Author:
Danning CAI
;
Yan JIANG
- Keywords:
Hubei province;
Drug;
Sampling and testing;
Quality status;
Suggestions for improvement
- From:
China Pharmacy
2017;28(1):126-130
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE:To evaluate the quality of sampling drugs of Hubei province,and to provide reference for drug enter-prises and supervision department. METHODS:The data obtained by Hubei Institute for Food and Drug Control about provincial drug sampling and testing from 2013 to 2015 were summarized,the overall quality and unqualified items were statistically analyzed according to current standard. RESULTS & CONCLUSIONS:The number of total sampling batches was 7721 and that of the un-qualified batches was 333 (4.3%) during 2013-2015. Most of the unqualified samples came from distribution units (2.8%-9.0%) and medical institutions (5.2% -11.7%). Among all sample types, the herbal medicine has the highest unqualified rate (12.1%-37.4%),with the largest number of unqualified items(content determination,supplement inspection item,property,resid-ual amount of sulfur dioxide,ash content). The quality of pharmaceutical preparations is relatively stable,and the unqualified items correlated with drug types and dosage forms. The current issues of provincial drug sampling and testing are the variety of standard levels,unreasonable sampling resource allocation and the low level of the industry. Supervision department is proposed to readjust drug standard,reasonably plan sampling and testing process and strengthen production source controlling.
