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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

An exceptional year at Kovsies — one of the most successful years in academic achievement
2014-12-04

 

The University of the Free State (UFS) had an exceptional year, with many staff members and students performing both nationally and internationally. Considerable progress has also been made in improving the academic standards of the university.

“So far, this has been one of the most successful years in academic achievement. The UFS now has the highest academic pass rate in years, partly as a result of the admission standards which were raised four years ago.

“We now also have the highest rate of research publications, one of the highest publication figures for scholarly books in history, three Mandela Rhodes scholars and several international communication awards”, says Prof Jonathan Jansen, Vice-Chancellor and Rector of the UFS.

“The university now attracts top professors from all over the country and other parts of the world and for the first time in many years, two researchers received A-ratings from the National Research Foundation (NRF). This is the first time in the history of the UFS that two A-ratings were awarded simultaneously. The most researchers ever were rated by the NRF this year. After the constant turmoil of a few years ago, Kovsies has now become one of the most stable campuses in South Africa,” Prof Jansen says.

The impartial findings of a recent survey of UFS stakeholders showed that our values are endorsed by 92%; 86% agrees with our vision; 81% agree with our goals; 77% agree with our transformation; 78% believe that we are inclusive; and 78% applauded our overall reputation index. “These figures are very different from a few years ago when the university experienced a crisis,” he says.
 
According to Prof Jansen, the UFS’s financial situation is one of the most stable of all universities in South Africa, with a strong balance sheet and growing financial reserves – way better than before. This is exactly the reason why the UFS received confirmation from the Independent Regulatory Board of Auditors (IRBA) this year that we complied with international standards of reporting for the financial year which ended on 31 December 2013.

“I am also pleased to report that the crisis in the delivery of health services in the Free State province has been resolved due to collaboration between the UFS Management (including the Dean: Health Sciences and Head of the School of Medicine), the Department of Health and the Premier, Mr Ace Magashule. Although the loss of skilled personnel is still a concern, the Dean and Head of the School of Medicine are recreating the Health Services Platform at Universitas Hospital. However, the academic training of no undergraduate medical student or any student in the Health Sciences was influenced by the crisis in the Universitas and Pelonomi Hospitals”, he says.

The UFS is regarded around the world as a model of transformation and reconciliation in the student body. The recent SRC elections are only the most visible example of how far we have come in terms of leadership diversity. “Not a week goes by in which other universities, nationally and abroad, do not come to Kovsies to consult with us on how they can learn from us and deepen their own transformations, especially among students”, Prof Jansen says.

“The UFS will continue its model of inclusive transformation which provides opportunities for study and for employment for all South Africans, including international students and colleagues. We remain committed to our parallel-medium instruction in which Afrikaans remains a language of instruction; we are in fact the only medical school in the country that offers education and training in Afrikaans and not only English. We provide bursaries and overseas study opportunities to all our students, irrespective of race. And our ‘future professors’ programme is richly diverse as we seek the academic stars of the future. But we remain steadfast in our goal of making the UFS a top world university in its academic ambitions and its human commitments,” Prof Jansen says.

 

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