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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-strengthening agent enhances natural ability of plants to survive
2015-07-27

Drought, diseases, and fungi. These are factors that farmers have no control over, and they often have to watch despondently as their crops are damaged. In addition, the practice of breeding plants in special and strictly-controlled conditions, has resulted in crops losing the chemical ability to protect themselves in nature.

Researchers in the Department of Soil, Crop, and Climate Sciences at the University of the Free State (UFS) have developed an organic agent that restores this chemical imbalance in plants. It enables the plant to build its own resistance against mild stress factors, and thus ensures increased growth and yield by the plant.

ComCat®, a plant-strengthening agent, is the result of extensive research by the German company, Agraforum AG, together with the UFS. Commercialisation was initially limited to Europe, while research was done at the UFS.

“Plants have become weak because they were grown specially and in isolation. They can’t protect themselves any longer,” says Dr Elmarie van der Watt from the department.

Dr Van der Watt says that, in nature, plants communicate by means of natural chemicals as part of their resistance mechanisms towards various stress conditions. These chemicals enable them to protect themselves against stress conditions, such as diseases and fungi (biotic conditions) or wind and droughts (abiotic conditions).

Most wild plant varieties are usually well-adapted to resist these stress factors. However, monoculture crops have lost this ability to a large extent.

The European researchers extracted these self-protection chemicals from wild plants, and made them available to the UFS for research and development.

“This important survival mechanism became dormant in monoculture crops. ComCat® wakes the plant up and says ‘Hey, you should start protecting yourself’.”

Research over the last few years has shown that the agent, applied mostly as a foliar spray, subsequently leads to better seedlings, as well as to growth, and yields enhancement of various crops. This is good news for the agricultural sector as it does not induce unwanted early vegetative growth that could jeopardise the final yield ? as happened in the past for nitrogen application at an early growth stage.

“The use of synthetic agents, such as fungicides which contain copper, are now banned. Nowadays, options for natural and organic agriculture is being investigated. This product is already widely used in Europe, but because farmers are often swamped by quacks, the South African market is still somewhat sceptical.”

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