Practical considerations for the Pharmaceutical Quality Control Laboratory during the COVID-19 pandemic

2020 ◽  
pp. 59-70
Author(s):  
M Brits
Keyword(s):  
Quality Control ◽  
Information Sources ◽  
Health And Safety ◽  
Easy Access ◽  
Administrative Staff ◽  
Control Laboratory ◽  
Pharmaceutical Quality ◽  
Quality Control Laboratory ◽  
Working Environments ◽  
Practical Guidance

A Pharmaceutical Quality Control Laboratory (PQCL) is one of the critical pillars in the quality assurance of medicines to ensure the availability of safe and efficacious medicines. It is thus of critical importance that the PQCL should be able to continue delivering its service to the greater public. With the reporting of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in December 2019 as the causative agent of COVID-19, a new health and safety threat was introduced into greater society and specifically the workplace. The aim of this manuscript is to provide practical guidance and easy access reference to information sources for PQCL managers in an attempt to ensure safer working environments for the analytical and administrative staff of PQCLs, and to support the continued availability of quality assured medicines world-wide during this pandemic.

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

scholarly journals Rematuration Periods and Sperm Characteristics of Litopenaeus vannamei

2007 ◽  
Vol 6 (1) ◽  
pp. 1
Author(s):  
L. Okmawati Anwar ◽  
K. Sumantadinata ◽  
O. Carman
Keyword(s):  
Quality Control ◽  
Litopenaeus Vannamei ◽  
Head Size ◽  
Control Laboratory ◽  
Quality Control Laboratory ◽  
Normal Sperm ◽  
Abnormal Sperm ◽  
Sperm Characteristics

<p>The reproduction ability of male has an important role in seeds production of <em>Litopenaeus vannamei</em>. The objective of research was to know the sperm characteristics from each rematuration period. The research conducted in Broodstock and Nauply Quality Control Laboratory, Central Pertiwi Bahari, Lampung Province on April until July 2006. Five male shrimps obtained from High Health, Aquaculture Inc., Hawaii-USA, about 39.4 ± 1.51 g in weight and 16.4 ± 0.43 cm in length. Carefull stripping was applied to release the mature spermatophore from the thelicum. The results showed that number of sperm at the first to fourth rematuration period relatively constant (33.62x10<sup>6 </sup>- 39.7402x10<sup>6</sup> cell). However the number of abnormal sperm were relatively increase slightly (1.2806x10<sup>6</sup> to 23.3576x10<sup>6 </sup>cell) and also the number of death sperm (0.293x10<sup>6 </sup>to 3.92x10<sup>6 </sup>cell) while the number of normal sperm were relatively decrease (29.1158x10<sup>6 </sup>to 23.3576x10<sup>6 </sup>cell). There were no changes in head size and tail lenght of the sperm from each rematuration periods.</p> <p>Keywords:  <em>Litopenaeus vannamei</em>, spermatozoa, rematuration</p> <p> </p> <p>ABSTRAK</p> <p>Kemampuan reproduksi udang jantan berperan penting dalam pembenihan udang vaname <em>Litopenaeus vannamei</em>. Penelitian ini bertujuan untuk mengetahui karakteristik sperma pada setiap periode rematurasi. Penelitian dilaksanakan di Laboratorium Kendali Mutu Induk dan Naupli, Central Pertiwi Bahari, Propinsi  Lampung, bulan April sampai Juli 2006. Udang jantan yang digunakan berasal dari High Health, Aquaculture Inc., Hawaii-USA, dengan ukuran berat 39,4 ± 1,51 g, panjang tubuh 16,4 ± 0,43 cm dan berjumlah lima ekor sebagai ulangan. Spermatofor dilepaskan dari telikum dengan teknik  pengurutan. Hasil penelitian menunjukkan jumlah sperma relatif stabil pada empat kali rematurasi (33,62x10<sup>6 </sup>- 39,7402x10<sup>6</sup> sel). Jumlah sperma abnormal dan sperma mati berbanding terbalik dengan jumlah sperma normal. Jumlah sperma abnormal meningkat dari rematurasi pertama hingga rematurasi ke empat (1,2806x10<sup>6</sup> ke 23,3576x10<sup>6 </sup>sel) demikian halnya<sup> </sup>jumlah sperma mati (0,293x10<sup>6 </sup>ke 3,92x10<sup>6 </sup>sel), sedangkan jumlah sperma normal mengalami penurunan (29,1158x10<sup>6 </sup>ke 23,3576x10<sup>6 </sup>sel). Tidak terdapat perubahan ukuran kepala dan panjang ekor sperma dalam setiap periode rematurasi.</p> <p>Kata kunci :  <em>Litopenaeus vannamei</em>, spermatozoa, rematurasi</p>

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