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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

2014 Winter Graduation
2014-06-27

 
It is time for the 2014 Winter Graduation on our Bloemfontein Campus. From 2 – 4 July 2014 Masters and Doctoral degrees will be bestowed on graduates from across all seven faculties as well as the School of Open Learning. These include the conferral of Medicine degrees on the South African Cuban trainees.

Wednesday 2 July 2014 at 14:30: School of Open Learning
The School of Open Learning will confer a total of 609 degrees this year – almost double compared to the 320 of last year.

Thursday 3 July 2014 at 09:30: Faculty of Natural and Agricultural Sciences
Prof Magdalena Blum will receive an Honorary Doctorat, DPhil honoris causa, at this event. Prof Blum is an Extension Systems Officer in Rome. She works for a specialised agency of the United Nations called the Food and Agriculture Organization. This organisation’s mandate is:
• to improve nutrition,
• increase agricultural productivity,
• raise the standard of living in rural populations and
• contribute to global economic growth.

Her position serves to modernise and strengthen rural advisory services, their systems and networks worldwide. She has filled this position for almost nine years.

Prof Blum is driven by a passion for development, humanitarian work and female upliftment, but most of all, to enable people to help themselves.

Blum’s life has taken her from a small German village to Africa, Asia and Europe – and she has made an impact wherever she went.

Thursday 3 July 2014 at 14:30: Faculties of Economic and Management Sciences, Humanities, Education, Health Sciences, Law and Theology
At this ceremony, Faculty of the Humanities will award an Honorary Doctorate, DPhil honoris causa, on Prof Laura Mulvey. She is a feminist film theorist and worked at the British Film Institute for many years. She is currently a professor at Film and Media Studies at Birkbeck, University of London.

Prof Mulvey was prominent as an avant-garde filmmaker in the 1970s and ‘80s. In collaboration with her husband, Peter Wollen, she co-wrote and co-directed:
• Penthesilea: Queen of the Amazons (1974),
• Riddles of the Sphinx (1977, perhaps their most influential film),
• AMY! (1980),
• Crystal Gazing (1982),
• Frida Kahlo and Tina Modotti (1982), and
• The Bad Sister.

In 1991, she returned to filmmaking with Disgraced Monuments, which she co-directed with Mark Lewis.

Friday 4 July 2014 at 10:30: Special Graduation Ceremony
Conferral of Medicine Degrees on the South African Cuban trainees at the UFS

Live streaming will be available on: http://www.ufs.ac.za/ufslivestreaming/

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