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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

Four modernised controlled environment cabinets inaugurated
2006-07-27

Photographed in a controlled environment cabinet were at the back from the left:  Mr Adriaan Hugo (head of the UFS Electronics and Mechanisation Division), Prof Herman van Schalkwyk (Dean: Faculty of Natural and Agricultural Sciences at the UFS) and Prof Koos Terblans (lecturer at the UFS Department of Physics).  In front is Mr Koos Uys (engineering consultant from Experto Designa who helped with the cooling systems of the cabinets).
Photo: Leonie Bolleurs

Different look for research in controlled circumstances at the UFS  

Research in controlled circumstances at the University of the Free State (UFS) turned a new page today with the inauguration of four modernised controlled environment cabinets of the Department of Soil, Crop and Climate Sciences.

“The controlled environment cabinets, which are situated next to the glass houses on the eastern side of the Agriculture Building on the Main Campus in Bloemfontein, were installed in the early 1980’s.  The cabinets, used for research purposes in controlled circumstances by the UFS for many years, became dysfunctional and needed to be repaired and put into use again,” said Prof Herman van Schalkwyk, Dean: Faculty of Natural and Agricultural Sciences at the UFS.

“The cabinets are used by the agronomics, horticulture and soil science divisions of the Department of Soil, Crop and Climate Sciences to control factors such as the temperature, the intensity and quality of light, synthesis and humidity.  This is done 24 hours a day, with hourly intervals,” said Prof Van Schalkwyk.

The cabinets are ideally suited to determine the joint and separate effects of these factors on the growth of plants.  The adaptability of plants to climate can also be investigated under controlled circumstances.  All of this leads to a better understanding of the growth and development process of plants, more specifically that of agricultural crops. 

“The effect of these environmental factors on the effectiveness of insect killers such as fungus killers, insecticide and weed killers can also be investigated and can help to explain the damage that is sometimes experienced, or even prevent the damage if the research is timeously,” said Prof Van Schalkwyk.

A new cabinet can cost between R2-3 million, depending on the degree of sophistication.  “Although controlled environment cabinets have been used for agricultural research for a long time, it has become costly to maintain them     and even more impossible to purchase new ones,” said Prof Van Schalkwyk.

According to Prof Van Schalkwyk the cabinets were re-built by die UFS Electronics and Mechanisation Division.  Some of the mechanisms were also replaced and computerised.   

“The re-building and mechanisation of the cabinets were funded by the faculty and because the work was done by our own staff, an amount of about R1 million was saved.  The maintenance costs will now be lower as the cabinets are specifically tailor made for our research needs,” said Prof Van Schalkwyk.

Where all monitoring was done manually in the past, the cabinets can now be controlled with a computer.  This programme was designed by Prof Koos Terblans from the UFS Department of Physics. 

According to Prof Van Schalkwyk the modernisation of the cabinets is part of the faculty’s larger strategy to get its instruments and apparatus up to world standards.  “With this project we have proved that we can find a solution for a problem ourselves and that there are ways to get old apparatus functional again,” said Prof Van Schalkwyk.

Media release
Issued by: Lacea Loader
Media Representative
Tel:   (051) 401-2584
Cell:  083 645 2454
E-mail:  loaderl.stg@mail.uovs.ac.za
26 July 2006

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