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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

UFS PhD student receives more than R5,8 million to take agricultural research to African farmers
2015-07-06

Prof Maryke Labuschagne and Bright Peprah. (Photo: Supplied)

Bright Peprah, a Plant Breeding PhD student from Ghana in the Department of Plant Sciences at the University of the Free State received an award from the competitive Program for Emerging Agricultural Research Leaders (PEARL) of the Bill and Melinda Gates Foundation (BMGF) for one of his projects.

From the more than 750 proposals for funding that were received from African researchers, only 19 received funding from PEARL. PEARL is an agricultural initiative by the BMGF to take agricultural research products to African farmers. It also aims at involving the youth and women in agriculture.

Peprah’s proposal to introgress beta carotene into farmer-preferred cassava landraces was part of the final 19 proposals funded. The project is being led by the Council for Scientific and Industrial Research (CSIR)Crops Research Institute (CRI), and has the International Institute of Tropical Agriculture (IITA) and the International Centre for Tropical Agriculture (CIAT) as international partners with Peprah as the principal investigator.


The development of nutrient-dense cassava cultivars needs attention to eliminate the ramifications of malnutrition among the poor in an inexpensive and more sustainable way.
Photo: Supplied

He received $473 000 (R5,8 million) for his project on the improvement of beta-carotene content in cassava.

Peprah decided on this project because the populations of underdeveloped and developing countries, such as Ghana, commonly suffer undernourishment and/or hidden hunger, predisposing them to diseases from micronutrients deficiencies. “Vitamin A deficiency constitutes an endemic public health problem which affects women and children largely,” he says.

“In Africa, cassava is widely consumed by the populace. Unfortunately, in these areas, malnutrition is endemic to a significant extent, partly due to the low micronutrients in this tuberous root crop, which is a major component of most household diets. It is for this reason that the development of nutrient- dense cassava cultivars needs much attention to eliminate the ramifications of malnutrition among the poor in an inexpensive and more sustainable way.

“To date we have selected top eight genotypes from germplasm collected from the International Institute of Tropical Agriculture (IITA) which are high in carotenoids and also poundable, a key trait to Ghanaian farmers. These eight genotypes have been planted at different locations in Ghana, and being evaluated by different stakeholders (consumers, researchers, producers, commercial farmers, processors, etc.). If found suitable, the genotypes will be released to farmers, which we hope will solve some of the micronutrient problems in Ghana.

“My projects seek to develop new cassava varieties that will have both high dry matter and beta carotene which has been reported to be negatively correlated (as one increase, the other decreases). The breeding method will be crossing varieties that are high in beta carotene with those with high dry matter, and checking the performance of the seedlings later. Developing such new varieties (yellow flesh cassava) will increase their adoption rate by Ghanaian farmers,” he said.

Prof Maryke Labuschagne, Professor in Plant Breeding in the Department Plant Sciences and Peprah’s study leader, said: “This project has the potential to alleviate vitamin A deficiency in the West African region, where this deficiency is rampant, causing blindness in many people, especially children."

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