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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

UFS institute set to contribute to transformation in South Africa
2011-01-23

The UFS launches it's new International Institute for Studies in Race, Reconciliation and Social Justice.
- Photo: Dries and Henco Myburgh

Today (Thursday, 27 January 2011), almost three years after the Reitz affair, the University of the Free State (UFS) is launching its International Institute for Studies in Race, Reconciliation and Social Justice. This international institute will be inaugurated by Archbishop Emeritus Desmond Tutu, Nobel Peace Prize Laureate and Chairperson of the former Truth and Reconciliation Commission, who received an honorary doctorate in Theology from the university earlier today.

According to Mr John Samuel, Interim Director of the institute and former Chief Executive Officer of the Nelson Mandela Foundation, the institute seeks to establish itself as a premier international site for research on race, reconciliation and social justice.

“It is encouraging to see the UFS bringing to the fore such an initiative, which combines a study in race, reconciliation and social justice, all of which are indispensible elements in the process of rebuilding our nation,” said the Deputy President of South Africa, Mr Kgalema Motlanthe, in his message of congratulations to the university.

“I am confident that on the strength of its stature, coupled with its eminent experience as an academic institution, the UFS will further assist our country advance towards a united, non-racial, non-sexism, just and prosperous future.

“I wish the institute well in its arduous but noble task of contributing to the building of a better human society,” he said.

Prof. Jonathan Jansen, Vice-Chancellor and Rector, stated during his official inauguration in 2009 that the university would be an example of a place where reconciliation, forgiveness and social justice would not only be studied, but where it would also be applied in practice. “Students and scholars from across the world will come to the UFS to study the theory and practice about the building of societies across the boundaries of race, as well as religion, gender, disabilities and national origin,” Prof. Jansen said.

The institute is a critical space where engaged scholarship, public discussion, community engagement and teaching are innovatively integrated towards exploring and finding solutions to the complex and challenging work of social transformation in South Africa.

The institute furthermore works towards the realisation of its mission through a multiplicity of approaches and methods, informed by the notion that deep and complex social challenges require courageous and challenging scholarship, supported by innovative organisational forms and institutional arrangements.

Working from the inside to the outside, the institute will firstly serve the needs of the university, its staff and students. Through its research, the institute will endeavour to understand the challenges facing the UFS better, as well as how to address these challenges. For this reason, the concept of the UFS as a “live laboratory” and the use of evidence-based practice remain important for the university.

The institute will also reach out and empower its stakeholder communities through research and ongoing involvement on issues of race, reconciliation and social justice. Furthermore the institution expects to contribute to the creation of national and international networks and dialogue platforms pertaining to race, reconciliation and social justice.

For the first five years, the themes of 1) Values, Faith and Social Justice; 2) Development and Social Cohesion; 3) Teaching and Learning for Social Justice; and 4) Provincial, National, Global Perspectives and Leadership will direct the institute’s work.

The UFS will make a substantial contribution to the pursuit of reconciliation, greater social cohesion and equity in South Africa. The university is thus prepared to continue to engage the difficult, practical and trying work of building a strong, quality institution as it promotes racial healing and addresses the structural imbalances of the past. It is at this nexus that the institute commits to enabling change at the university as well contributing to transformation in South Africa.

Deputy President Kgalema Motlanthe's message of support to the University of the Free State (PDF format)

Media Release
27 January 2011
Issued by: Lacea Loader
Director: Strategic Communication (actg)
Tel: 051 401 2584
Cell: 083 645 2454
E-mail: news@ufs.ac.za

 

 

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