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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

Award-winning photographer exhibits ravages of war, 25 May 2016 until 17 June 2016
2016-06-02

Description: Unsettled exibition Tags: Unsettled exibition

The ruins of the Dimbaza Border Industrial Park built
in the 1970s as a source of cheap labour for industrialists
and ostensible employment for Ciskei Homeland citizens.
This industrial zone collapsed after 1994.
Photo: Images courtesy of the Galerie Seippel. 
All images © Cedric Nunn

Cedric Nunn’s latest photographic exhibition, Unsettled: One Hundred Years War of Resistance by Xhosa Against Boer and British, opened on 25 May 2016 at the Johannes Stegmann Art Gallery of University of the Free State, and will run until 17 June 2016. Since 2014, the exhibition has travelled through South Africa and the USA as well as Germany.

The photographer, documentary film-maker, and artist’s photographic journey was launched in the early 1980s in Durban. In 2011, he won the first FNB Joburg Art Fair Award.

Narratives of the victors and the vanquished

Unsettled deals with the nine wars that Xhosa people were subjected to between 1779 and 1879 in their fight against Afrikaner and British colonial settler forces. Nunn’s art seeks to instigate social change, and highlight lesser-seen aspects of society.

The work emanated from his awareness of a notable gap in the telling of this piece of South African history, as well as the fact that, to date, little has been done to memorialise these acts of colonial aggression and Xhosa resistance. He decided to document the land where these struggles took place.

“Through revisiting this painful past in the contemporary scenes of today, this work attempts to place the present in its factual context of dispossession and conquest,” said Nunn.

Unsettled
forms the first component of what will be a trilogy. The next component will address the legacy of colonial dispossession through “bringing ‘the first inhabitants’ back into the picture by giving a select number of self-describing Khoi, Griqua, and San or Bushmen a contemporary face and presence”. The final component will look at slavery.

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