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13 May 2019 | Story Zama Feni | Photo Charl Devenish
Dr Quinton Meyer and Marlena Visagie
National Control Laboratory Deputy Director, Dr Quinton Meyer (right), and Marlena Visagie, Quality Assurance Manager, at the laboratory within their facilities at the University of the Free State.

The University of the Free State-based National Control Laboratory for Biological Products (NCL) has maintained its esteemed status as a pharmaceutical testing laboratory after the South African Accreditation System (SANAS) further endorsed its quality-management systems as of high standard according to the International Standards Organisation’s requirements.

The Director of the NCL, Professor Derek Litthauer, said their laboratory – which is also approved by the World Health Organisation (WHO) – has again achieved the international testing standards. The cherry on top was that the NCL also received a certificate of Good Manufacturing Compliance (GMP) from the South African Health Products Regulatory Authority (SAHPRA). 

NCL is for Africa and the World 

Some of the factors that make the NCL an esteemed institution, is the fact that it is one of 12 laboratories worldwide to perform vaccine testing for the WHO; the NCL is 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 SAHPRA. 

For example, Prof Litthauer said that the influenza vaccine batches currently available on the South African market, were tested by the NCL for quality before authorising their release for sale to the public. This process is followed for all human vaccines used in SA.

 “In our role as 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. 
The NCL was one of the first full members of the WHO NCL Network for Biologicals, which consists of full and associate members of regulatory authorities from more than 30 countries.

The NCL systems are world-class

Prof Litthauer said this achievement is recognition that their laboratory complies with specific international standards with respect to its quality-management system. 
“In practice, it means that the laboratory has all the quality systems in place to ensure high-quality test results. The GMP certification is a further step, meaning that laboratory testing is on the expected level for any pharmaceutical testing laboratory and manufacturer. It is a very strict certification.”

He further mentioned that the NCL is also licensed as a pharmaceutical manufacturer. “Although we do not manufacture, we have 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. It means that the NCL complies with exceptionally strict standards for pharmaceutical labs anywhere in the world,” he said.
The certification provides the South African Health Products Regulatory Authority, the World Health Organisation, and other national control laboratories around the world, with the confidence that the test results from the NCL can be trusted.


There can be no compromise for quality 

The NCL Quality Assurance Manager, Mrs Marlena Visagie, said, “It is essential that the NCL complies with the highest international quality-assurance standards to ensure that all the lot-release operations, such as manufacturing review and quality testing, are performed in a reliable and reproducible manner.”

“There can be no compromise when it comes to the quality of medicines which are made available to the public,” she said.

“What makes this special, is that the NCL does not only comply with international ISO/IEC standards for pharmaceutical testing, but also with the additional GMP standards required by a pharmaceutical manufacturer. This means that the NCL must ensure that all its operations, including everything 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.”

All NCL staff share vision of excellence

Prof Litthauer said the NCL has a staff complement of 15 technical, administrative, and support staff.  Four staff members have PhDs, and the rest of the technical staff have master’s or bachelor’s degrees or are trained as medical technologists. “At the moment, our biggest problem is to get enough suitable space to expand our testing,” he said.

Prof Litthauer said, “All the staff members at the NCL share the vision of excellence, which makes this kind of achievement possible.”
The NCL will host the third annual meeting of the WHO NCL Network in November of this year and will then be reassessed again by the WHO as part of the normal three-year cycle of assessments.  

News Archive

Research into veld fires in grassland can now help with scientifically-grounded evidence
2015-04-10

While cattle and game farmers are rejoicing in the recent rains which large areas of the country received in the past growing season, an expert from the University of the Free State’s Department of Animal, Wildlife, and Grassland Sciences, says that much of the highly inflammable material now available could lead to large-scale veld fires this coming winter.

Prof Hennie Snyman, professor and  researcher in the Department of Animal, Wildlife, and Grassland Sciences, warns that cattle and game farmers should be aware, in good time, of this problem which is about to rear its head. He proposes that farmers must burn firebreaks as a precaution.

At present, Prof Snyman focuses his research on the impact of fire and burning on the functioning of the grassland ecosystem, especially in the drier grassland regions.

He says the impact of fire on the functioning of ecosystems in the ‘sour’ grassland areas of Southern Africa (which includes Kwazulu-Natal, Limpopo, Mpumalanga, the Eastern Cape, and the Harrismith environs) is already well established, but less information  is available for ‘sweet’ semi-arid grassland areas. According to Prof Snyman, there is no reason to burn grassland in this semi-arid area. Grazing by animals can be effectively used because of the high quality material without having to burn it off. In the sourer pasturage, fire may well form part of the functioning of the grassland ecosystem in view of the fact that a quality problem might develop after which the grass must rejuvenate by letting it burn.

Prof Snyman, who has already been busy with the research for ten years, says quantified data on the impact of fire on the soil and plants were not available previously for the semi-arid grassland areas. Fires start frequently because of lightning, carelessness, freak accidents, or damaged power lines, and farmers must be recompensed for this damage.

The shortage of proper research on the impact of fires on soil and plants has led to burnt areas not being withdrawn from grazing for long enough. The lack of information has also led to farmers, who have lost grazing to fires, not being compensated fairly or even being over-compensated.

“When above-and below-ground plant production, together with efficient water usage, is taken into account, burnt grassland requires at least two full growing seasons to recover completely.”       

Prof Snyman says farmers frequently make the mistake of allowing animals to graze on burnt grassland as soon as it begins to sprout, causing considerable damage to the plants.

“Plant roots are more sensitive to fire than the above-ground plant material. This is the reason why seasonal above-ground production losses from fire in the first growing season after the fire can amount to half of the unburnt veld. The ecosystem must first recover completely in order to be productive and sustainable again for the long term. The faster burnt veld is grazed again, the longer the ecosystem takes to recover completely, lengthening the problem with fodder shortages further.  

Prof Snyman feels that fire as a management tool in semi-arid grassland is questionable if there is no specific purpose for it, as it can increase ecological and financial risk management in the short term.

Prof Snyman says more research is needed to quantify the impact of runaway fires on both grassland plant productivity and soil properties in terms of different seasonal climatic variations.

“The current information may already serve as valuable guidelines regarding claims arising from unforeseen fires, which often amount to thousands of rand, and are sometimes based on unscientific evidence.”

Prof Snyman’s research findings have been used successfully as guidelines for compensation aspects in several court cases.

 

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