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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

New challenges for animal science discussed
2006-04-04

Some of the guests attending the congress were from the left Dr Heinz Meissner (honorary president of the South African Society for Animal Science (SASAS) and senior manager at the Animal Production Institute of the Agricultural Research Council), Mr Paul Bevan (President of SASAS) and Prof Magda Fourie (Vice-Rector:  Academic Planning at the UFS).
Photo: Lacea Loader

New challenges for animal science discussed  

The South African Society for Animal Science (SASAS) is presenting its 41st Congress at the University of the Free State’s (UFS) Main Campus in Bloemfontein. 

The congress started yesterday and will run until Thursday 6 April 2006.  The theme is New challenges for the animal science industries.

It is one of the largest congresses in the 45 years since SASAS was founded in 1961.  Among the delegates 12 African countries are represented, with the biggest delegation from Kenya.  Delegates are also from the United States of America, Iran, Turkey, Germany, the Netherlands and Portugal and African countries like Zimbabwe, Mozambique and Botswana.

“Many of our members play an important role in the training of animal scientists at universities.  The congress is specifically industry orientated so that scientists can interact with farmers through the respective producer organisations,” said Prof HO de Waal, Chairperson of the organising committee and lecturer at the UFS Department of Animal, Wildlife and Grassland Sciences.

According to Dr Heinz Meissner, honorary president of SASAS and a senior manager at the Animal Production Institute of the Agricultural Research Council, the National Livestock Strategy (NLS) Plan clarifies the role and responsibility of the livestock sector. 

“Through this strategy we need to focus on enhancing equitable access and participation in livestock agriculture, improve global competitiveness and profitability of the livestock sector and ensure that the ventures implemented do not over utilise our resources,” said Dr Meissner.

In her welcoming address, Prof Magda Fourie, Vice-Rector:  Academic Planning at the UFS highlighted the related challenges that the UFS will be focusing on specifically over the next five years.  “We have identified five strategic clusters that represent broad areas of excellence in research and post-graduate education.  Two of these are food production, quality and safety for Africa and sustainable development,” she said.

“The food safety and security cluster will focus on the production of food in all its varieties within the African context, encompassing the entire value chain – from production to consumption and nutrition related issues.  This would include a strong emphasis on sustainable production systems,” she said.

According to Prof Fourie the rural development cluster will engage in questions around the role of higher education in sustainable development.  “One of the focus areas in this strategic cluster pertains to sustainable livelihoods.  It refers to a way of approaching development that incorporates all aspects of human livelihoods and means by which people obtain them,” she said.

Prof Fourie said that the challenges we are facing such as food production can only be effectively addressed through collaborative efforts.  “That is why it is important that collaboration takes place between different scientific disciplines, researchers, institutions and countries who are confronted with similar difficulties,” she said.

According to Prof de Waal the congress will give key role players a unique opportunity to present a profile of what they perceive an animal scientist should be and state their specific requirement regarding the animal sciences and its applications. 

“In this way we can determine what the industry’s needs are and we can re-align our curriculum to suit these needs,” said Prof de Waal.

During the next two days, various areas of interest will be discussed.  This includes ruminant and monogastric nutrition, animal physiology, beef, dairy, sheep and ostrich breeding and sustainable farming covering the range from commercial to the small-scale farming level.

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

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