Analytical validation in practice at a quality control laboratory in the Japanese pharmaceutical industry

1997 ◽  
Vol 2 (3) ◽  
pp. 140-145 ◽  
Author(s):  
S. Seno ◽  
S. Ohtake ◽  
H. Kohno
Keyword(s):  
Quality Control ◽  
Pharmaceutical Industry ◽  
Control Laboratory ◽  
Analytical Validation ◽  
Quality Control Laboratory

scholarly journals COVID-19 vaccines: progress and understanding on quality control and evaluation

2021 ◽  
Vol 6 (1) ◽  
Author(s):  
Qunying Mao ◽  
Miao Xu ◽  
Qian He ◽  
Changgui Li ◽  
Shufang Meng ◽  
...  
Keyword(s):  
Quality Control ◽  
Global Health ◽  
Research And Development ◽  
Drug Evaluation ◽  
Control Laboratory ◽  
Vaccine Candidates ◽  
Regulatory Authorities ◽  
Quality Control Laboratory ◽  
Leading Role ◽  
National Quality

AbstractThe outbreak of COVID-19 has posed a huge threat to global health and economy. Countermeasures have revolutionized norms for working, socializing, learning, and travel. Importantly, vaccines have been considered as most effective tools to combat with COVID-19. As of the beginning of 2021, >200 COVID-19 vaccine candidates, covering nearly all existing technologies and platforms, are being research and development (R&D) by multiple manufacturers worldwide. This has posed a huge obstacle to the quality control and evaluation of those candidate vaccines, especially in China, where five vaccine platforms are deployed in parallel. To accelerate the R&D progress of COVID-19 vaccines, the guidances on R&D of COVID-19 vaccine have been issued by National Regulatory Authorities or organizations worldwide. The Center for Drug Evaluation and national quality control laboratory in China have played a leading role in launching the research on quality control and evaluation in collaboration with relevant laboratories involved in the vaccine R&D, which greatly supported the progression of vaccines R&D, and accelerated the approval for emergency use and conditional marketing of currently vaccine candidates. In this paper, the progress and experience gained in quality control and evaluation of COVID-19 vaccines developed in China are summarized, which might provide references for the R&D of current and next generation of COVID-19 vaccines worldwide.

POOR OBSTETRIC OUTCOME IN THREE QUALITY CONTROL LABORATORY WORKERS

The Lancet ◽  
1983 ◽  
Vol 321 (8331) ◽  
pp. 983-984 ◽  
Author(s):  
RoyG. Farquharson ◽  
MarionH. Hall ◽  
WilliamT. Fullerton
Keyword(s):  
Quality Control ◽  
Obstetric Outcome ◽  
Control Laboratory ◽  
Quality Control Laboratory ◽  
Laboratory Workers
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