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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 casts its net wider for collaborative partner engagement
2015-10-19

Ms Felicia Mabuza-Suttle and Mr Ndaba Ntsele

The office of Institutional Advancement at the University of the Free State hosted an event on 9 October 2015 in Johannesburg, to engage prospective partners and donors, to showcase its various projects and programmes, and to recognise existing donors for their contributions.

The event, titled “Revenge of the Caterpillar”, prompted a discussion on the story of change at the University of the Free State, focusing on transformation as well as new ways of advancing a University amidst recent events.

The programme director, Mr Ndaba Ntsele, CEO and Director of Pamodzi Holdings and member of the UFS Council, introduced the Vice-Chancellor and Rector, Prof Jonathan Jansen, to the audience. Mr Ntsele expressed his deep respect and confidence in the Vice-Chancellor and his leadership of the university.

Professor Jansen launched his new book, Leading for Change: Race, intimacy, and leadership on divided university campuses, which offers theoretical grounds for thinking about, and transforming, leadership and higher education worldwide. In the context of his book, Prof Jansen discussed inter-racial relationships among students at the UFS and their experiences, which mirror race relations in the country among communities that have come out of a long history of oppression, such as slavery and apartheid.

Prof Jansen also spoke of the challenges that have surfaced nationally on racial symbols on university campuses. “At the UFS, we have dealt with issues concerning racial symbolism.  It is important to lead in times of peace, in order to be able to lead in times of trouble,” he said.

A robust discussion followed, on the way forward for transformation at institutions of higher education, and how this affects communities and the nation at large.   The event was attended by representatives of donor and affiliate organisations of the UFS, such the Nedbank Group, The South African Holocaust and Genocide Foundation, and celebrity guests such as Gareth Cliff, Felicia Mabuza-Suttle and Leanne Manas.



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