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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

Lecture focuses on how Marikana widows embody the transformative power of art
2015-08-11

Makopane Thelejane

"When I got the news of my husband is dead, I put my hands above my head, as you see me in this picture. I could not bear the ache in my heart." - Makopane Thelejane

A woman looks down on a canvas covered in thick layers of red, dark shadows falling across her face. A brief moment that captures the silently-devastating aftermath of the Marikana massacre that bled into the lives of 34 widows.

It is this silent trauma that was at the centre of the last instalment of the Vice-Chancellor’s Lecture Series for 2015. “These stories of the Marikana widows are important. It is these stories of silence that live behind the spectacular scenes of the violence,” Prof Pumla Gobodo-Madikizela, Senior Research Professor in Trauma, Forgiveness, and Reconciliation Studies at the University of the Free State (UFS) said at the event.

Panel
The lecture, which took place on Monday 27 July 2015 on the Bloemfontein Campus, took the form of a panel discussing the theme of “Speaking wounds: voices of Marikana widows through art and narrative”. The panel consisted of members from the Khulumani Support Group, including Dr Marjorie Jobson (National Director) and Judy Seidman (Sociologist and Graphic Artist), as well as Nomfundo Walaza, former CEO of the Desmond Tutu Peace Centre.

Betty Lomasontlo Gadlela

"Then this dark time came, a dark cloud over me. It made me to have an aching heart, which took me to hospital, from losing my loved one, my husband, in such a terrible manner. " - Betty Lomasontlo Gadlela

Trauma made visible
In a project initiated by Khulumani, the Marikana widows were encouraged to share their trauma through painting body maps – in which the widows depicted their own bodies immersed in their trauma – and narrating their personal stories. Throughout the workshops, the focus always remained on the women. As Siedman put it, “the power of this process is rooted in the participants. The statements of what the participants experienced is what’s important.”

Initially silenced and isolated, this group of women has now moved “into a space where they have become connected to each, and stand up for each other in the most powerful ways,” Dr Jobson said. “Our work is conceptualised in terms of giving visibility and voice to the people who know what it takes to change this country; to change this struggle.”

The transformative power of art and narrative
During her response, Walaza pointed out “how art and narrative can transform traumatic memory and become integrated in the survivors’ life story.” This gives individuals the opportunity, she said, “to step into a space of mutual listening and dialoguing in which people bond together.”

Co-hosted by Prof Gobodo-Madikizela and the UFS Institute for Reconciliation and Social Justice, the lecture series forms part of a five-year research project funded by the Andrew W. Mellon Foundation.

 

 

 

 

 

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