Implementation and interpretation for proficiency testing of microbiological examination
10.12173/j.issn.2097-4922.202405092
- VernacularTitle:微生物限度检查能力验证组织及解读
- Author:
Zhiyuan LI
1
;
Jingyi ZHANG
;
Siqi WANG
;
Zheyuan LI
;
Yi LIU
;
Weibin ZOU
Author Information
1. 云南省食品药品监督检验研究院,工业和信息化部产业技术基础公共服务平台,昆明 650106
- Keywords:
Proficiency testing;
Non-sterile drugs;
Microbiological examination;
Implementation and interpretation
- From:
China Pharmacist
2024;28(10):229-236
- CountryChina
- Language:Chinese
-
Abstract:
Objective To understand the testing performance of drug manufacturers and testing institute in Yunnan province by organizing proficiency testing of microbiological examination of non-sterile drugs,and to improve the testing performance and quality management level of participants by interpretation of unsatisfactory results.Methods According to the requirements of relevant China National Accreditation Service for Conformity Assessment (CNAS),preparation values of positive or negative was determined as assigned values for qualitative items,and the median value was as assigned value for enumeration items.Using robust statistical methods and Z-score for assessment,if all the 4 items were satisfactory,it would be assessed as overall satisfactory performance,and contrariwise,it would be assessed as unsatisfactory performance.If partial item were satisfactory,it would be assessed as partially satisfactory performance.Results 152 laboratories participated in this proficiency testing program,116 laboratories obtained satisfactory performance and the satisfactory rate was 76.31％;33 laboratories obtained partially satisfactory performance,and the partially satisfactory rate was 21.71％;3 laboratories obtained unsatisfactory performance and the unsatisfactory rate was 1.97％.To classify the participants with type,the satisfactory rate for drug control institute was 88.23％ and the satisfactory rate of drug manufacturers was 74.81％.Conclusion The testing performance of participating laboratories in microbiological examination of non-sterile drugs is generally good,which can ensure the smooth implementation of the program and the accuracy and effectiveness of the results.The testing capacity and quality management level of a few laboratories need to be improved.
