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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 Faculty of Theology and Jonathan Edwards Centre at Yale University forge strategic partnership
2009-06-10

 
Prof. Francois Tolmie, Dean of the UFS’s Faculty of Theology.
Photo: Supplied


The Faculty of Theology at the University of the Free State (UFS) will establish a Jonathan Edwards Centre for Southern Africa, affiliated with the Jonathan Edwards Center at Yale University in New Haven in the United States of America.

This strategic partnership exemplifies the vision of the Faculty of Theology to be an internationally renowned theological and training faculty.

The UFS Jonathan Edwards Centre will serve as a research, education and publication hub for the study of Edwards and evangelical history and develop links with the international academic community.

Prof. Francois Tolmie, Dean of the Faculty of Theology at the UFS, said, “I welcome the plans to pay sustained critical attention to Edwards’s thought. Jonathan Edwards was an important American theologian, philosopher and more specifically America's greatest contributor to mission theology in Southern Africa.”

Dr Kenneth Minkema, Executive Director of the Jonathan Edwards Center at Yale University, adds: “The establishment of the Jonathan Edwards Center Southern Africa at the UFS in Bloemfontein is a significant expansion of Edwards scholarship and will serve widely both academia and the church.”

Jonathan Edwards (1703-1758), pastor, revivalist, Christian philosopher, missionary, and president of Princeton University, is widely regarded as North America’s greatest theologian. He is the subject of intense scholarly interest because of his significance as an historical figure and the profound legacy he left on America’s religious, political and intellectual landscapes.

In recent years, a rapidly growing interest in Edwards as theologian has brought the man and his writings onto the world stage, pressing beyond the popular and more parochial image of Edwards primarily as American preacher and American historic figure. Increasingly, his writings are being consulted by religious leaders, pastors, and churches around the world, spurred by a growing recognition of the fervency and universality of the Edwards message and the acumen with which he appraised religious experience.

This interest in Edwards globally has been fuelled in part by the work of the Jonathan Edwards Centre at Yale University, whose sole mission is to support inquiry into the life, writings, and legacy of Jonathan Edwards by providing resources that encourage critical appraisal of the historical importance and contemporary relevance of America’s premier theologian. The primary means to achieve this is with the The Works of Jonathan Edwards Online, a digital learning environment for research, education and publication that presents all of Edwards’s writings, along with helpful editorial materials that allow the reader to examine Edwards's thought in incredibly powerful, useful ways. The Works of Jonathan Edwards Online 2.0 is accessible through the Centre’s website at: www.edwards.yale.edu.

Media Release:
Mangaliso Radebe
Assistant Director: Media Liaison
Tel: 051 401 2828
Cell: 078 460 3320
E-mail: radebemt.stg@ufs.ac.za
10 June 2009

 

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