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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

Postgraduate Film and Visual Media Programme at UFS from 2015
2014-12-04

 

There is great excitement at the University of the Free State (UFS) about the approval of a new honours and master’s programme in Film and Visual Media to be offered at the Faculty of the Humanities as from January 2015.

Prof Suzanne Human, Head of the Department of Art History and Visual Culture Studies at Kovsies and Director of the new programme, says this will be an interdisciplinary Film and Visual Media programme. There will consequently be a strong theoretical-philosophical basis in the training, as well as the practical experiences of students. The UFS will be the only university in South Africa where this much emphasis is placed on the historical and theoretical aspects of film-making.

“The world of images is, in our day and age where we are overwhelmed by images on a daily basis, a central study field relevant across various disciplines and even links the natural and human sciences,” says Prof Human.

“Film, which replaced books in the lives of young people in many ways, is an exciting field of which most people have some knowledge and involves a broad field of information with wide relevance.”

The programme will be presented with the cooperation of international scholars and experienced experts from the local industry. Chris Vorster – better known as Ryno from 7de Laan – with more than 20 years of experience in writing, directing and performance for theatre and TV, was appointed as lecturer in Film-making Theory and Practice in the newly-built film studio as from 2 January 2015.

This new postgraduate programme is developed in cooperation with several UFS departments:
• Prof Suzanne Human and Johanet Kriel (History of Art and Visual Culture Studies);
• Prof Nico Luwes, Dr Pieter Venter and Debeer Cloete (Drama and Theatre Arts);
• Prof Helene Strauss (English);
• Dr Anthea van Jaarsveld and Dr Cilliers van den Berg (Afrikaans and Dutch, German and French).

Specific admission requirements apply. For example, students should have a related BA degree with a minimum achievement level of 65%. Admissions are limited and subject to selection, therefore students that are interested should apply as soon as possible.  

Admission requirements

For more information, please send an email to filmandvisualmedia@ufs.ac.za.

 

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