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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

21 Icons: 21 Years of Freedom Collection at the University of the Free State
2015-09-02

   

In Prayer and Protest - Sophia Williams De Bruyn

The Johannes Stegmann Art Gallery, in partnership with 21 Icons, is hosting the 21 Years of Freedom Collection, an exhibition specially curated for the University of the Free State.
21 Icons celebrates a heroic past and inspires a hopeful future. The project was launched in 2013 as an initiative that uses film, photography and written narrative to celebrate the lives of extraordinary South Africans. It highlights people who have been catalysts in shaping society, on a local or global level and across a variety of contexts: in a social, political, environmental or artistic sense.

It is the brainchild of internationally renowned photographer and filmmaker Adrian Steirn, whose primary source of inspiration was the life of Nelson Mandela. In one way or another, all of the men and women featured in the project have extended his legacy, making a magnificent impact on South Africa and beyond.

  

Beautiful Sacrifice - Albie Sachs

21 Years of Freedom features 21 icons from the first and second seasons of the project. It includes the last official photographic portrait of Nelson Mandela and many of his friends and fellow struggle heroes. Behind each portrait lies a carefully planned concept that captures the essence of each icon, capturing their spirit and distinct legacy.

Among the other extraordinary South Africans featured in this collection, are struggle icons Ahmed Kathrada and Advocate George Bizos, Archbishop Desmond Tutu, human rights and environmental activist Kumi Naidoo, celebrated storyteller Gcina Mhlophe, Nobel laureate Nadine Gordimer, activist and musician Yvonne Chaka Chaka, gender activist Sophia Williams De Bruyn and artist William Kentridge.

    

The Full Report - Zubeida Jaffer

The 21 Icons was created as a movement for positive change. By sharing the stories of iconic South African men and women, the intention is to inspire new generations to follow in their footsteps.  With the country celebrating 21 years of democracy but still grabbling with injustices, the message that everyone can do something to make a difference, is portrayed in these powerful and inspiring stories.

Writer-in-residence and well-respected journalist, Zubeida Jaffer, who features among the collection of 21 striking photographs, opened the exhibition saying, “I feel like I’m surrounded by a circle of energy from which I have been fortunate to draw strength …It’s a choice that we make…whether to draw energy from those who are positive and forward looking or to surround ourselves with people who are fearful.  There is a lot to be fearful about in our country. We have lived through very fearful and difficult times.  But to cope with these times, those people and many others have kept their focus on hope.  They have kept their focus on what is possible…and what we would like South Africa to be in the future.”

For more information on 21 Icons: 21 Years of Freedom Collection contact the Johannes Stegmann Art Gallery at +27 (0)51 401 2706 or dejesusav@ufs.ac.za

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