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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

Student receives international award in microbiology
2008-01-24

A postgraduate student at the University of the Free State (UFS) received an exceptional honour last month when he received the first prize for his presentation in the Biochemistry and Industrial Mycology session of the Asian Mycology Congress (AMC) held in Malaysia.

Desmond Ncango (24), a Ph.D. student from the Department of Microbial, Biochemical and Food Biotechnology received the first prize for his presentation on the inhibitory effects of non-steroidal anti inflammatory drugs (NSAIDs) such as aspirin on fungi.

This suggests that commonly used aspirin may be used as a cheap antifungal to combat yeast infections. Desmond also exposed novel lubricants that are used by yeasts for water-propelled movement. This may find application in nanotechnology in the lubrication of nanorobots, which are manmade miniature machines, invisible to the naked eye, which may in future be used to combat diseases such as cancer.

The conference, which was attended by more than 300 representatives from 27 countries, is a platform for mycologists (who are experts in fungi) around the world to come together and share their knowledge and research. “Many interested researchers listened to my presentation and were impressed by the novelty and scientific depth of my work,” said Desmond.

“The presentation was selected as the best because of its novelty, academic depth as well as applicability. The meticulous preparation and presentation style also contributed to the success,” said Prof. Lodewyk Kock, head of the Lipid Biotechnology Group at the department and main promoter of Desmond’s Ph.D. studies.

“I cannot really explain the feeling when my presentation was selected as the best as it was presented in a very difficult category and many senior researchers and professors also participated. I plan to use all the knowledge and skills I have learnt from Prof. Kock, who is my role model, especially to the benefit of disadvantage communities in South Africa. I want to follow an academic career at a tertiary institution when I have completed my Ph.D. studies,” said Desmond.

Desmond went to school in Botshabelo, Bloemfontein and completed his Grade 12 in 2000 with a distinction in Mathematics. He enrolled for a B.Sc. degree at the UFS, majoring in Microbiology and Physiology. After obtaining this qualification, he joined the postgraduate research group of Prof. Kock. He completed his M.Sc. degree with distinction last year and was privileged to have this research published in and on the cover of the Canadian Journal of Microbiology, a journal accredited by the Institute for Scientific Information (ISI).

He was one of six postgraduate students from the Lipid Biotechnology Group who attended the AMC conference in Malaysia. The students’ attendance was funded by the South African Fryer Oil Initiative (SAFOI), which is housed in the UFS Department of Microbial, Biochemical and Food Biotechnology. This initiative, steered by Prof. Kock, currently monitors edible oils in the food industry in South Africa and makes a quality seal available to the manufacturers and distributors of these edible oils.

“SAFOI’s income is used to fund my own research on various kinds of oils (including yeast oils) to enable postgraduate students to attend international congresses and to partially fund international scientific symposia and congresses,” said Prof. Kock.

 

Media Release
Issued by: Lacea Loader
Assistant Director: Media Liaison
Tel: 051 401 2584
Cell: 083 645 2454
E-mail: loaderl.stg@ufs.ac.za 
24 January 2008

 

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