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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

#Women'sMonth: Save the children
2017-08-10

Description: Trudi O'Neill Tags: : rotaviruses, young children, Dr Trudi O’Neill, Department of Microbial, Biochemical and Food Biotechnology, vaccine 

Dr Trudi O’Neill, Senior lecturer in the Department of
Microbial, Biochemical and Food Biotechnology.
Photo: Anja Aucamp

Dr Trudi O’Neill, Senior lecturer in the Department of Microbial, Biochemical and Food Biotechnology, is conducting research on rotavirus vaccines.

Dr O’Neill was inspired to conduct research on this issue through her fascination with the virus. “The biology of rotaviruses, especially the genome structure and the virus’ interaction with the host, is fascinating.”

“In fact, it is estimated that, globally, ALL children will be infected with rotavirus before the age of five, irrespective of their socio-economic standing. However, infants and young children in poor countries are more vulnerable due to inadequate healthcare. The WHO estimates that approximately 215 000 deaths occur each year. This roughly equates to eight Airbus A380 planes, the largest commercial carrier with a capacity of approximately 500 seats, filled with only children under the age of five, crashing each week of every year.”

Alternative to expensive medicines 
“Currently, there are two vaccines that have been licensed for global use. However, these vaccines are expensive and poor countries, where the need is the greatest, are struggling to introduce them sustainably. It is therefore appealing to study rotaviruses, as it is scientifically challenging, but could at the same time have an impact on child health,” Dr O’Neill said.

The main focus of Dr O’Neill’s research is to develop a more affordable vaccine that can promote child vaccination in countries/areas that cannot afford the current vaccines.

All about a different approach 

When asked about the most profound finding of her research, Dr O’Neill responded: “It is not so much a finding, but rather the approach. My rotavirus research group is making use of yeast as vehicle to produce a sub-unit vaccine. These microbes are attractive, as they are relatively easy to manipulate and cheap to cultivate. Downstream production costs can therefore be reduced. The system we use was developed by my colleagues, Profs Koos Albertyn and Martie Smit, and allows for the potential use of any yeast. This enables us to screen a vast number of yeasts in order to identify the best yeast producer.”

Vaccination recently acquired a bad name in the media for its adverse side effects. As researcher, Dr O’Neill has this to say: “Vaccines save lives. By vaccinating your child, you don’t just protect your own child from a potentially deadly infection, but also other children in your community that might be too young to be vaccinated or have pre-existing health problems that prevents vaccination.” 

A future without rotavirus vaccination?

Dr O’Neill believes a future without rotavirus vaccination will be a major step backwards, as the impact of rotavirus vaccines has been profound. “Studies in Mexico and Malawi actually show a reduction in deaths. A colleague in Mozambique has commented on the empty hospital beds that amazed both clinicians and scientists only one year after the introduction of the vaccine in that country. Although many parents, mostly in developed countries, don’t have to fear dehydrating diarrhoea and potential hospitalisation of their babies due to rotavirus infection anymore, such an infection could still be a death sentence in countries that have not been able to introduce the vaccine in their national vaccination programmes,” she said. 

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