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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

Researchers focus on parrots, poultry and phage therapy
2014-10-10

Photo: en.wikipedia

Veterinary biotechnology focuses on microbial and molecular biological approaches to veterinary illnesses. The group working on veterinary biotechnology research at the University of the Free State (UFS) consists of two academic staff members, Prof Rob Bragg and Dr Charlotte Boucher, two post-doctoral fellows, Drs Chris Theron and Arina Hitzeroth, five PhD and three honours students.

The group has three research focus areas.

Dr Boucher says, “Our main focus area is infectious coryza in poultry, caused by the bacterium Avibacterium paragalliarum. The aim is the control of the disease, mainly through improvement of vaccines, understanding the immune response and improved biosecurity. A key objective is improving methods for serotyping; studying of selected surface antigens and investigating the influence recently discovered bacteriophages might have on virulence. We have co-operative projects with research groups in China, India and Israel.

“The second focus area is an expression system co-developed with the National Institute for Agronomic Research (INRA), France. The flagship project is the expression of the coat protein gene of the beak and feather disease virus, a disease affecting parrots, currently threatening the endangered Cape parrot. This system has led to the development of serological tests, currently under patenting. The application of this system has been extended to human-related diseases, with two interdisciplinary projects underway, co-working with Profs Muriel Meiring and Felicity Burt. Prof Meiring is working on diseases causing bleeding disorders, such as blood-clotting impairment, while Prof Burt is working on viral infections causing haemorrhagic (bleeding) disorders.

“We are also researching disease control in a post-antibiotic era, investigating the potential of phage-therapy by targeting and destroying pathogenic islands within a host, with reduced side-effects on the host itself.

“We have smaller projects, including an interdisciplinary project with Zoology, looking at the protein profile of amphibian (frog) secretions with the focus on antimicrobial activity, as these secretions assist with protecting amphibian skin against infections.”  


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