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11 February 2021 Photo UFS photo archive
The National Control Laboratory for Biological Products (NCL) Building.
There can be no compromise when it comes to the quality of medicines made available to the public.

The UFS-based National Control Laboratory for Biological Products (NCL) is a full member of the international WHO-National Control Laboratory Network for Biologicals and one of 12 laboratories worldwide contracted to perform vaccine testing for the World Health Organisation (WHO). The NCL is also the only vaccine-testing laboratory in the country that performs the final quality-control testing of all human vaccine batches marketed in South Africa on behalf of the South African Health Products Regulatory Authority (SAHPRA).

In its role as a vaccine-testing laboratory for the WHO, the NCL helps to ensure that the vaccines purchased through the WHO prequalification programme for international distribution to resource-limited countries, meet the high standards of quality, safety, and efficiency. 

International testing standards

The laboratory received the status of a pharmaceutical testing laboratory after the South African Accreditation System (SANAS) endorsed its quality-management systems as of a high standard according to the International Standards Organisation’s requirements.

With its international testing standards, the NCL must ensure that all its operations – from the way documents are compiled and stored, to the maintenance of equipment and infrastructure, as well as staff competency – are performed according to international guidelines.

The laboratory has all the quality systems in place to ensure high-quality test results. The certificate of Good Manufacturing Compliance received in 2019 indicates that laboratory testing is on the expected level for any pharmaceutical testing laboratory and manufacturer. This certification is very strict and means that the NCL complies with exceptionally strict standards for pharmaceutical labs anywhere in the world. The certification offers the South African Health Products Regulatory Authority, the WHO, and other national control laboratories around the world the confidence that the test results from the NCL can be trusted.

Licensed as pharmaceutical manufacturer

The laboratory is also licensed as a pharmaceutical manufacturer. Although the lab does not manufacture, it needs to comply with manufacturing standards. It is rare for a pharmaceutical testing laboratory (such as the NCL) outside of a manufacturing context to qualify for both certifications.

News Archive

Little ‘Devil’s Worm’ on Top 10 New Species list
2012-05-29

 

Halicephalobus mephisto (Devil’s Worm)
Photo: Supplied
29 May 2012

A minuscule little worm found and researched with the assistance of researchers at the university has made it onto the list of Top 10 New Species of the world. The list was published by the International Institute for Species Exploration (IISE) at Arizona State University and a committee of scientists from around the world. It lists the top ten new species described in 2011.

An article on the new worm species appeared in the authoritative journal Nature in June 2011.
 
Prof. Esta van Heerden, leader of the university’s research team, says, “In our wildest dreams, we could not have imagined that we would get so much reaction from the worm’s discovery. We had to do so many checks and balances to convince Nature that the worm could survive in the old and warm water. We were very excited when the article was accepted but the media reaction was unbelievable.”
 
The tiny nematode, Halicephalobus mephisto (Devil’s Worm) of about 0,5 mm in length, is the deepest-living terrestrial multi-cellular organism on earth. It was discovered in the Beatrix gold mine near Welkom at a depth of 1,3 km.
 
The IISE says in a statement the species is remarkable for surviving immense underground pressure as well as high temperatures. The borehole water where this species lives has not been in contact with the earth’s atmosphere for the last 4 000 to 6 000 years.  
 
This top-10 list includes a sneezing monkey; a beautiful, but venomous jellyfish; a fungus named after a popular TV cartoon character; a night-blooming orchid; an ancient walking cactus creature; and a tiny wasp. A vibrant poppy, a giant millipede and a blue tarantula also made it onto the list.
 
The international selection committee made its choice from more than 200 nominations. They looked for species that captured the attention because they were unusual or because they had bizarre traits. Some of the new species have interesting names.
 
Prof. Van Heerden says, “We are very thankful for the exposure that the university gets as a result of the inclusion on the list and we enjoy the international cooperation immensely.”

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