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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

Plant scientist, Prof Zakkie Pretorius, contributes to food security with his research
2014-08-26

 
Many plant pathologists spend entire careers trying to outwit microbes, in particular those that cause diseases of economically important plants. In some cases control measures are simple and successful. In others, disease management remains an ongoing battle. 

Prof Zakkie Pretorius, Professor in the Department of Plant Sciences, works on a group of wheat diseases known as rusts. The name is derived from the powdery and brown appearance of these fungi.

Over the course of history wheat rusts have undergone what are notoriously known as boom and bust cycles. During boom periods the disease is controlled by means of heritable resistance in a variety, resulting in good yields. This resistance, though, is more often than not busted by the appearance of new rust strains with novel parasitic abilities. For resistance to remain durable, complex combinations of effective genes and chromosome regions have to be added in a single wheat variety.

In recent years, Prof Pretorius has focused on identifying and characterising resistance sources that have the potential to endure the onslaught of new rust races. His group has made great progress in the control of stripe rust – where several chromosome regions conditioning effective resistance have been identified.

Dr Renée Prins of CenGen and an affiliated UFS staff member, developed molecular markers for these resistance sources. These are now routinely applied in wheat breeding programmes in South Africa. In addition, Prof Pretorius collaborates with several countries to transfer newly discovered stem rust resistance genes to wheat, and in characterising effective sources of resistance in existing wheat collections.

His work is closely supported by research conducted by UFS colleagues, students and other partners on the genetics of the various wheat rust pathogens. These studies aim to answer questions about:
• the origin and relatedness of rust races,
• their highly successful parasitic ability, and
• their adaptation in different environments.

The UFS wheat rust programme adds significantly to the development of resistant varieties and thus more sustainable production of this important crop. 

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