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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

Inaugural lecture: World on verge of agricultural revolution
2008-05-19

A changing economic climate and new technology will see to a number of interesting changes in the livestock industry in the next few years. This is according to Prof. Frikkie Neser of the Department of Animal and Wildlife and Grassland Sciences, who delivered his inaugural lecture at the UFS on the subject: “The quest for a superior animal”.

Prof. Neser focused on the future of animal breeding in the next few decades.

He said the world, but especially South Africa, stand on the verge of a revolution in the agriculture sector. The whole production scenario will probably change. The high fuel and food prices are the two biggest factors that will play a role.

“Increasing fuel prices opened the door for the production of bio-fuel. The fuel industry is in direct competition with humans and the livestock industry for the same resource that result in unbelievable high prices for maize, sunflower and soya. These prices can further increase with the worldwide shortage of food,” he said.

More profitable breeds could take the place of existing breeds because of the big increase in input costs, he said. “Selection for more effective, and not maximum production, will became more important.

“There are also indications of pressure on feed lots. If this industry downsizes, it could lead to a total turnaround in the beef industry. The feed lots prefer a later maturing animal that can put on a lot of weight before fat is laid down. If this industry declines, early maturing breeds and some of the synthetic breeds, as well as crossbreeding with early maturing breeds, will play a more prominent role in the meat industry.

“This will also lead to a decline in the total number of animals in order to prevent overgrazing. This can result in an increase in imports from neighbouring countries and especially Brazil, where production costs are much lower.

“One way to increase the profitability of meat production is to utilise niche markets. There is world-wide a shift to more natural products. The demand for grass-fed beef drastically increased. According to research it is healthier than meat from feed lots and usually free of hormones and antibiotics. If factors such as traceability are put in place, this could be a very profitable niche mark for the South African meat industry,” he said.

Prof. Neser also said: “In order for breeding societies to survive they need to increase the number of members and the animals that are being registered. This they do by replacing the word stud with recorded animals. Hereby they open the door for excellent commercial animals to become part of the seed-stock industry. Another benefit is that especially in the smaller breeds more information becomes available, resulting in more accurate breeding values.”

Prof. Frikkie Neser.

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