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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 staff among proud PhD graduates
2013-06-28

Prof Dave Lubbe with his two daughters, Leandi Steenkamp (left) and Nandi Lubbe.
Photo: Stefan Lotter

An exceptional moment at this year's graduation ceremony was when the two daughters of an academic, Prof Dave Lubbe of the Centre for Accounting, obtained their master's degrees. "It is indeed a highlight in my career that my daughters received their master's degrees cum laude at the same graduation ceremony, under my supervision!"

Prof Lubbe's two daughters, Nandi Lubbe and Leandi Steenkamp, both received their MCom with distinctions in Accounting. They completed their degrees under the supervision of Prof Lubbe and Nandi also won the Dean's medal as the best M student in the Faculty of Economic and Management Sciences.

Julia Ramabenyane Mamosebatho and Emmie Smit. Julia, of the Faculty of Education: School for Social Sciences and Language Education, received her PhD in Curriculum Studies. Her thesis was on The facilitative role of Grade 1 teachers in the development of reading skills in Sesotho. Emmie, from the Office of the Dean: Education, did her thesis on Appreciating the University of the Free State's transformation: A juxtaposed journey with Alice to Wonderland. With this, she obtained her PhD in Higher Education Studies.

 

Merridy Wilson-Strydom and Deidre van Rooyen. Merridy obtained her PhD in Higher Education Studies. Her thesis A framework for facilitating the transition from school to university in South Africa: A capabilities approach, is a comprehensive and ambitious research project that was accomplished with great academic mastery. With her thesis, Civic culture and local economic development in a small town, Deidre obtained her PhD in Development Studies.

 

 
 The Institute for Groundwater Studies (IGS) boasted with five students who received their doctor’s degrees at this Winter Graduation. They are, from the left, front: Vierah Hulley, Chris Moseki, Ferdie Linde, Abdon Atangana and Jacob Nyende. Back is Prof Jopie Botha, Prof Gerrit van Tonder and Dr Danie Vermeulen.

 

 

Modulathoko Irvin Mabokgole received his master's degree in Mathematical Statistics and Actuarial Science. He also received the Senate Medal for best master's student at the university.

 

 

Dave Mills obtained his master's degree in Practical Theology.

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Manie Moolman received his PhD in Higher Education Studies. With his thesis, Competence directives for enhancing the employability of hospitality management graduates in South Africa, he addresses one of the most important challenges facing higher education training in hospitality management, namely the training of employable graduates.

 

 

Jo-Marí Visser obtained her PhD in Criminal and Medical Law. With her thesis First generation forensic evidence and its influence on legal decision-making: A South African perspective, she investigates forensic evidence and the collection thereof at the crime scene.

 

Maralize Conradie received her master's degree in Commercial Law. The subject of her thesis is A critical analysis of the right to fair labour practices.

 

Jan Beukes received his PhD in Music – Performing Arts. This lecturer at the Odeion School of Music's thesis is titled: Oorwegings by die realisering en dokumentering van 'n duet- of duo-orreltranskripsie van Fauré se Requiem (op. 48).

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