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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

Artistic development at UFS to transform the face of Bloemfontein creatively
2015-07-02

The 7-metre high ‘Urban Fox’ is one of Alex Rinsler's artworks adding a fragment of the wild to the city of Shanghai in China.

Bold, bright, and beautiful public art sculptures are in the inception phase at the university’s Bloemfontein Campus. Manchester-based public artist, Alex Rinsler, of the Programme for Innovation in Artform Development (PIAD)’s forum for artist development, is to install three enthralling sculptures in the city of Bloemfontein.

The PIAD forum for artist development is an initiative of the Vrystaat Arts Festival, formerly known as the Vryfees, which aims to celebrate art in the Free State by hosting experimental art practices. In its capacity as a PIAD partner, the University of the Free State promotes increased access to, and participation in, culture as a form of human development.

Presenting an artist’s talk titled ‘Urban Safari: Art in public space,’ on the Bloemfontein Campus recently Rinsler introduced himself and his creative ideas to students, staff, and the public at the Johannes Stegman Art Gallery. The talk served as an invitation to the active participation of Bloemfontein citizens in all phases leading to the installations. Dispersed across the Mangaung Metropolitan, the giant sculptures are intended to capture and reflect different aspects of the community’s lived experiences. 

As a public artist based in the United Kingdom (UK), Rinsler has exhibited in cities nationally and internationally, with the intention of bringing a touch of the wild to urban lives. His vision is to witness the development of cities into cultural boulevards, and explore “what we can do to bring back the sense of nature, the wild” by adding new symbolism to urban lifestyle.

“I believe in creating work accessible to the public, which stimulates conversation,” said the Clore Leadership Programme Fellow (University of Manchester) and Founder of Pirate Technics - an artistic practice company.

In 2012, he worked with 31 Master’s students from 24 countries on an icon for global peace named “Under the Baobab” in London. The colourful and magnificent Baobab tree made from pieces of fabric representing distinct cultures told the story of migration to London.

Rinsler is determined that the Bloemfontein “project, similar to the London installation, will create imagery that people will remember.”

Dr Ricardo Peach, Director of the Vrystaat Arts Festival and PIAD, hopes the project fosters diversity while producing a “communal cultural product." 

“What I know about Alex’s work is that he will be working with what he calls a self-selected community, people who are interested in this, and who want to work together to build these sculptures, as part as a process for them to get a sense of where they belong, and their input into the city. It’s about people telling their own stories.”

The public installations are a way of transforming the landscape, and connecting people of “a place like Bloemfontein where communities are often still so divided,” said Peach.

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