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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 responds to media reports about UFS101
2012-08-18

The UFS101 is a cross-disciplinary module of the University of the Free State (UFS) that encourages critical thinking and offers access to knowledge beyond the specific qualifications for which students are registered. This is a multi-disciplinary academic curriculum that includes topics in astronomy, nanotechnology, history, law, anthropology and religion.

Throughout the seven units students are taught to think broadly rather than narrowly, and critically rather than through rote-learning.

The core curriculum module raises some difficult questions about science, humanity and the universe that have occupied human beings for centuries. There is considerable effort put into the module to enable balance, respect, and independent thinking. Students are not taught what to think but are offered different perspectives on difficult issues.

“In my unit on the question ‘how should we deal with the past?’ every effort is made for students to examine the perspectives on history held by people from different communities in South Africa,” said Prof. Jonathan Jansen, Vice-Chancellor and Rector of the UFS.

Students are then encouraged to speak in class, online and in tutorial groups where they are given ample opportunities to take a position and defend it not through emotion and anger, but through logic and reason.

The objective of the module is to equip students to deal with “the present past” in constructive and empathetic ways. They are also prepared to become active citizens outside the classroom and gain skills they can use anywhere in the world.

Some students find the module difficult at first, since most of them are not used to the practice of critical thinking and dealing with difficult questions from the past, the present and the future. Most students gradually come to enjoy the core curriculum module as they become accustomed to a new style of teaching and learning.

There are 700 first-year modules at the UFS. This is the only one module offered to students in English so that all students, local and international, can engage with one another directly on the subject matter discussed in the module. However, the module material is also available in Afrikaans online.It is a pity that AfriForum Jeug Kovsies did not discuss their concerns with the presenters of the module, but chose to do it through the media.

It is a pity that AfriForum Jeug Kovsies did not discuss their concerns with the presenters of the module, but chose to do it through the media.

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