Home Journals Articles Updates About
CN
image
收藏切换
Analysis of Results of Three NMPA's Microbial Proficiency Testing Programs
收藏切换
PDF
Jiwei LU1, Yiling FAN1, 2, Zhukang CHEN1, Guangzhi GU1, Songqing GU1, *, Meicheng YANG2, 3, Xiaoming GAO4, Xinhua XIANG4, *
Chinese Pharmaceutical Journal | 2025, 60(3) : 308 - 312
Less
收藏切换
Chinese Pharmaceutical Journal | 2025, 60(3): 308-312
Analysis of Results of Three NMPA's Microbial Proficiency Testing Programs
Full
Jiwei LU1, Yiling FAN1, 2, Zhukang CHEN1, Guangzhi GU1, Songqing GU1, *, Meicheng YANG2, 3, Xiaoming GAO4, Xinhua XIANG4, *
Affiliations
  • 1 NMPA Key Laboratory for Testing Technology of Pharmaceutical Microbiology, Shanghai Quality Inspection and Testing Center for Innovative Biological Products,Shanghai Institute for Food and Drug Control, Shanghai 201203, China
  • 2 China State Institute of Pharmaceutical Industry, Shanghai 201203, China
  • 3 Shanghai Food and Drug Packaging Material Control Center, Shanghai 201203, China
  • 4 National Institutes for Food and Drug Control, Beijing 100050, China
Published: 2025-02-08 doi: 10.11669/cpj.2025.03.014
Outline
收藏切换

OBJECTIVE To analyze the results of three NMPA's Microbial Proficiency Testing Programs, NIFDC-PT-288, NIFDC-PT-340, and NIFDC-PT-446, to evaluate the microbiological testing abilities of laboratories nationwide in drug detection, thus the regulatory agencies can learn the microbiological proficiency status of drug inspection laboratories and the laboratories can improve the microbiological detection ability. METHODS The results of the three proficiency testing programs were analyzed regarding the satisfaction rate, identified problems, and key technical points, and the laboratory types, number of laboratories and capability of the laboratories participating the three proficiency testing projects were analyzed. RESULTS The result satisfaction rates of provincial food and drug inspection institutions were 95.7% (NIFDC-PT-288), 86.4% (NIFDC-PT-340) and 100.0% (NIFDC-PT-446), while the satisfaction rates of municipal food and drug control institutions were 95.5% (NIFDC-PT-288), 83.9% (NIFDC-PT-340) and 92.5% (NIFDC-PT-446), respectively. The satisfaction rates of enterprise laboratory were 86.7% (NIFDC-PT-288), 65.7% (NIFDC-PT-340) and 80.2% (NIFDC-PT-446), respectively. The satisfaction rates of other types of laboratories were 100.0% (NIFDC-PT-288), 61.5% (NIFDC-PT-340) and 86.7% (NIFDC-PT-446), respectively. CONCLUSION The successful implementation of the three microbiological proficiency testing programs has provided the laboratories with effective external quality control means, and it also provides the first-hand reference for regulatory authorities on the microbiological testing capability of nationwide drug laboratories. The qualitative microorganism testing ability of drug laboratories is basically good, while the quantitative microorganism testing ability needs to be improved.

microbiological proficiency testing program  /  Staphylococcus aureus  /  total aerobic microbial count  /  total molds and yeasts count  /  proficiency result analysis
Jiwei LU, Yiling FAN, Zhukang CHEN, Guangzhi GU, Songqing GU, Meicheng YANG, Xiaoming GAO, Xinhua XIANG. Analysis of Results of Three NMPA's Microbial Proficiency Testing Programs[J]. Chinese Pharmaceutical Journal, 2025 , 60 (3) : 308 -312 . DOI: 10.11669/cpj.2025.03.014
Appendix
Less
Year 2025 volume 60 Issue 3
PDF
101
44
Cite this Article
BibTeX
Article Info
doi: 10.11669/cpj.2025.03.014
  • Receive Date：2024-06-04
  • Online Date：2025-10-29
  • Published：2025-02-08
Article Data
Affiliations
History
  • Received：2024-06-04
Affiliations
    1 NMPA Key Laboratory for Testing Technology of Pharmaceutical Microbiology, Shanghai Quality Inspection and Testing Center for Innovative Biological Products,Shanghai Institute for Food and Drug Control, Shanghai 201203, China
    2 China State Institute of Pharmaceutical Industry, Shanghai 201203, China
    3 Shanghai Food and Drug Packaging Material Control Center, Shanghai 201203, China
    4 National Institutes for Food and Drug Control, Beijing 100050, China
References
Share
https://castjournals.cast.org.cn/joweb/zgyxzz/EN/10.11669/cpj.2025.03.014
Share to
QR

Scan QR to access full text

Cite this article
BibTeX
Citations
表12种不同金属材料的力学参数
科
Family		 属数
Number of
genus		 种数
Number of
species		 占总种数比例
Percentage of
total species (%)		 属
Genus		 种数
Number of
species		 占总种数比例
Percentage of total
species (%)
鹅膏菌科Amanitaceae 2 11 5.26 鹅膏菌属 Amanita 10 4.78
小菇科 Mycenaceae 2 12 5.74 丝盖伞属 Inocybe 5 2.39
多孔菌科 Polyporaceae 8 14 6.70 蜡蘑属 Laccaria 5 2.39
红菇科 Russulaceae 3 23 11.00 小皮伞属 Marasmius 6 2.87
小菇属 Mycena 11 5.26
光柄菇属 Pluteus 5 2.39
红菇属 Russula 17 8.13
栓菌属 Trametes 5 2.39
关闭全屏
  • BibTeX
  • EndNote
  • RefWorks
  • TxT
Links
Articles
Latest Articles
Most Read
Collections
Updates
Events
News
Multimedia
About
About Us
Contact
No. 86 Xueyuan South Road, Haidian District, Beijing
100081
010-62199257
qkjq@cast.org.cn

Copyright © 2025 China Association for Science and Technology. All rights reserved. For all open access content, the relevant licensing terms apply.
Sponsored by the Office of the Leading Group for Cybersecurity and Informatization of CAST, and supported by Science and Technology Review Publishing House