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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 makes history as a second researcher – Prof Melanie Walker – receives NRF A-rating
2014-12-03

Prof Melanie Walker
Photo: Sonia Small

Prof Melanie Walker, Senior Research Professor at the University of the Free State’s (UFS) Centre for Research on Higher Education and Development (CRHED) has received an A1 rating from the National Research Foundation (NRF). This rating acknowledges Prof Walker as a leading international researcher – her work unequivocally recognised by peers world-wide for its high quality and wide impact.

This is the first time in our institution’s history that two A-ratings are awarded simultaneously. Prof Maxim Finkelstein from the Department of Mathematical Statistics also recently received an A2-rating in Probability and Statistics from the NRF.

“Achieving this outstanding rating,” Prof Walker says, “is not just an individual achievement. I have had tremendous personal support and rich intellectual collaborations from wonderful colleagues on the way. The award also recognises the Rector’s project to build a dynamic research culture at UFS.”

Prof Walker has been researching and writing about issues in education and higher education for over 20 years. In particular she is interested in opportunities into, through and beyond education across dimensions of dis/advantage, and how higher education contributes to building a decent society by removing inequalities in its own policies and processes.

Through her focus on capacity building – around the common theme of higher education, human development and social justice – Prof Walker is developing a dynamic cohort of new-generation scholars. Her research group of graduate students and post-doctoral fellows is drawn from countries not only in Africa, but as far afield as Finland, India and Vietnam.

Her networks attract international scholars to the UFS, who contribute to research projects, engage graduate students, and add a considerable contribution to research at our university.

In addition, Prof Walker fulfils a host of roles, which includes:

• Tier One National Research Foundation (NRF) Chair in Higher Education and Human Development.
• Vice-President of the international Human Development and Capability Association (HDCA).
• Fellow of the Academy of Science of South Africa (ASSAf).
• Honorary professor, University of Nottingham, UK.

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