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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

Leadership and responsible citizenship: key themes at the Global Leadership Summit
2015-07-09

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Leadership and responsible citizenship have been the main topics of discussion at the Global Leadership Summit which started on 5 July at the UFS Campus in Bloemfontein, and will continue until 17 July. More than 103 international delegates from various universities in Asia, the United States, and Europe, as well as 40 student delegates from the University of the Free State, are attending.

Kick-starting the summit talks was Prof Joel Samoff (Stanford University) who led discussions on transformation in institutions around the world. “Transformation is a constantly-changing interaction.  It is not a single objective, but a process, “ he said. This was followed by a robust panel discussion with student leaders of the UFS and those from James Madison University, Mount Holyoke College, and Rutgers University, who described the journey of transformation at their various universities.  “Young people are leading themselves in a different way, the context of the society we live in has changed,” said a UFS Student.

Keynote speaker, Zelda la Grange, gave an account of her experiences and the colourful journey of discovery of a “different” South Africa, working with President Nelson Mandela for 19 years, a journey that is the subject of  her book, “Good Morning Mr Mandela “. Under the theme “Breathing the same air: A metaphor for human solidarity, Prof Pumla Gobodo-Madikizela, Senior Research Professor in Trauma, Forgiveness, and Reconciliation Studies led a talk with Candice Mama, the daughter of slain anti-apartheid activist, Gelnack Masilo Mama, one of the victims of the former hit squad commander, Eugene de Kok. Candice inspired the audience with her philosophy on life and letting go of trauma: “Forgiveness is a process, and one needs to forgive to be able to be liberated from anger and bitterness,” she said.

Dr Lis Lange, Vice Rector: Academic, UFS spoke of citizenship and freedom, focusing on the responsibility that humans have to create ethical, positive, and meaningful interaction in their daily lives and in their societies across the globe.

As part of the programme, delegates will visit the Qwaqwa Campus on 10 July 2015, where they will interact with the leadership of the campus, its staff, and students, and enjoy an arts and cultural experience of the Eastern Free State.  The summit will end with a visit to various sites in Bloemfontein, where delegates will engage in community-based outreach activities in disadvantaged communities around the city. 

UFS to host second Global Leadership Summit

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