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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

Esteemed Tutu family honorary guests at first intercontinental symposium
2013-10-08

 

08 October 2013
Photo: Karina Turok

The University of the Free State (UFS) will be hosting a visit by Archbishop Desmond Tutu and Mrs Leah Tutu. The occasion is to launch the Annual Intercontinental Leah Tutu Symposium on rape and violence against women in honour of Mrs Tutu, who has been an outspoken advocate of women’s rights and the sanctity of family life.

The Inaugural Intercontinental Leah Tutu Symposium will take place on:

Thursday 17 October 2013
12:00-14:00
Scaena Theatre


The launch of the Annual Intercontinental Leah Tutu Symposium is organised by Profs Pumla Gobodo-Madikizela (who hosts the Dialogue between Science and Society lecture series) and Heidi Hudson (Director of the Centre for Africa Studies). The Inaugural Intercontinental Leah Tutu Symposium will feature gender and policy analyst Nomboniso Gasa as keynote speaker and Sheila Meintjes, Wits University professor with expertise in gender politics, violence and conflict transformation. The event will also feature voices of survivors of rape and sexual violence, including Johannesburg businesswoman and social entrepreneur, Andy Kawa, who is a survivor of rape and started the organisation Enuf is Enuf to campaign for an end to rape and sexual violence.

On Mrs Tutu’s 80th birthday, during the family’s visit to the UFS, Archbishop Desmond Tutu will also be in conversation with the Vice-Chancellor and Rector, Prof Jonathan Jansen, at a public event: Celebration of a partnership: Archbishop Tutu pays tribute to his wife, on the topic: Man to Man: The Meaning of Leah in My Life.

Thursday 17 October 2013
16:30-18:00
Centenary Complex


The public event is part of the Dialogue between Science and Society lecture series, in collaboration with Mrs Grace Jansen and the Tutu Legacy Foundation.

Please RSVP to Anja Pienaar at pienaaran@ufs.ac.za or +27(0)51 401 7330 or Jo-Anne Naidoo at naidooja@ufs.ac.za or +27(0)51 401 7160.

Two of their daughters, Rev Mpho Tutu and Dr Thandeka Tutu-Gxashe, will accompany Archbishop Desmond and Mrs Leah Tutu.

Short Bio of Mrs Leah Tutu

Nomalizo Leah Tutu is an outspoken advocate for the rights of women and the sanctity of family life. She was awarded an Honorary Doctorate in 2000 by the National Louis University in Atlanta for her commitment to human rights and support of her husband’s work. She is patron of the Phelophepa Train, a health project that brings medical care to people living in remote areas of South Africa. She is also a patron of the Tshwaranang Centre that provides legal advocacy to end violence against women. With Archbishop Tutu, Mrs Tutu is a patron of the Tygerberg Children’s Hospital in Cape Town. She, Archbishop Tutu, and family established the Desmond and Leah Tutu Legacy Foundation in 2012.

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