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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

Inaugural lecture challenges leaders in higher education
2012-10-30

Dr Mamphela Ramphele
Photo: Stephen Collett
29 October 2012


Lecture
(Pdf format)

According to international statistics, South Africa’s school performance is rated 140th out of 144 countries. South Africa is also ranked 143rd out of 144 countries when it comes to  the quality of mathematics and science. About 600 000 South African graduates are unemployed and about 500 000 learners are failed by our current education system.

Dr Mamphela Ramphele brought these shocking statistics to the light at the inaugural lecture of the Annual Prestige Lecture at the Faculty of Education on Thursday 25 October 2012 at the University of the Free State (UFS).

This lecture will henceforth be known as the Mamphela Ramphele Prestige Lecture.

Dr Ramphelefocused her lecture on ‘Educating the 21st century citizen’.

“One of the defining characteristics of the 21st century is the vast number of choices that confront us every day at a personal, professional and political level.”

She asked if 21st century South Africans are equipped with the skills to make the choices that confront them daily.

“The failure to transform our apartheid education into one characterized by equity and excellence, is producing graduates who lack self-confidence.”

Dr Ramphele said that in South Africa about 1/6th of government expenditure goes to education, but the outcomes remain shocking.

For Dr Ramphele the answer lies in creating platforms for open conversation about South Africa’s painful past and the agenda for radical socio-economic restructuring should include the fundamental transformation of education.

She praised the UFS, under its current inspirational leadership, for its role as change agents through the education.

Prof. Rita Niemann, senior professor at the Faculty said the Annual Mamphela Ramphele lecture is to further expand and celebrate education in South Africa.

“Dr Ramphela has given us so much food for thought by challenging leaders in higher education to speak out about the questionable state of education in South Africa and to become engaged in the ‘revolution of the spirit’ in order to deliver citizens who own and shape the country.”
 

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