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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

Art and science help us understand the world and our place in it
2017-10-28



Description: Art and science  Tags: Art and science

At the event were, from the left: Tristan Nel, first-year Fine Arts student;
Dr Janine Allen-Spies from the Department of Fine Arts;
Prof Carlien Pohl-Albertyn from the Department of Microbiology,
Biochemical and Food Biotechnology; and Pheny Mokawane, a
Microbiology, Biochemical and Food Biotechnology student.
Photo: Charl Devenish

Although BioArt dates back as far as the 15th and 16th centuries with the work of Leonardo da Vinci, it is not every day that art and science combine. This rare phenomenon made its appearance when two totally different groups of students – studying arts and microbiology respectively – joined hands in an initiative to create BioArt.

This first-time undergraduate teaching collaboration between the Departments of Fine Arts and Microbial, Biochemical and Food Biotechnology at the University of the Free State (UFS), which is characterised by the use of living materials, such as enzymes, microbes and DNA, as well as scientific tools and methods, is exploring a number of questions. 

Different outcomes for arts and microbiology students

According to Prof Carlien Pohl-Albertyn from the Department of Microbiology, Biochemical and Food Biotechnology, one of the central questions explored in BioArt is the nature of ‘life’. “At which stage can matter be classified as being alive or living?” she asked. 

“We realised that the outcomes for the two groups of students would not be the same. For the microbiology students, the focus would be on the understanding and effective communication of a microbiological concept. For the art students the focus would be on the execution of the assignment using visual elements and applied theory of art,” said Prof Pohl-Albertyn.

Dr Janine Allen-Spies from the Department of Fine Arts added: “Art students will also be exploring strangely or previously unforeseen gaps between art and science that can be filled with imaginative interpretations which may forward creative insights in both BioArt as a developing art form and microbiology as investigative science.”

Students’ understanding of microbial evolution reflected in art
The art students had to visit the microbiology labs for their assignment as this is mostly a foreign environment for these students. “The paint medium they had to use was gouache. This medium with its bright colours works well to depict microscopic organisms in art,” Dr Allen-Spies said. 

On display at the Department of Microbial, Biochemical and Food Biotechnology on the Bloemfontein Campus, at a recent event to introduce this new initiative to a wider audience, was a range of visually and scientifically compelling paintings and artefacts (such as paintings, poems, songs, apps) which explore a theme within microbiology from a BioArt perspective that uses creativity to communicate concepts dealt with in the module Microbial Evolution and Diversity.

Any parties who are interested in buying the art can contact Dr Allen-Spies at allenj@ufs.ac.za.

Paintings and artefacts reflects students understanding of BioArt. At the recent opening of the BioArt exhibition at the UFS Department of Microbial, Biochemical and Food Biotechnology, was the work of Madeleen Jansen van Rensburg on display.

Pheny Mokawane, a Microbiology, Biochemical and Food Biotechnology student, wrote a poem for his BioArt project in the Microbial Evolution and Diversity assignment. 

 

 

 

 

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