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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 research project aims to stimulate reflection on theological studies
2017-06-20

Description: Book, Theology and post Apartheid condition  Tags: Book, Theology and post Apartheid condition

The first book in the ‘UFS Theological
Exploration’ academic series, called Theology
and the Post(Apartheid) Condition
, has just
been released.
Photo: Supplied

 

The first study book with the title Theology and the Post(Apartheid) Condition, which is part of a new academic series by the Faculty of Theology and Religion at the University of the Free State, is now available. Volume 1, compiled by Professor Rian Venter as editor, is the first book in the ‘UFS Theological Exploration’ academic series, which the faculty plans to release.

Transformation
Professor Venter says the transformation of processes and practices in communicating and creating knowledge has become an urgent task for public universities in a democratic South Africa. Much reflection has already gone into the methods and scope of transformation in higher education.

Although the faculty has done work on the implications of this for theology, there is one area of investigation that has not received much attention. It concerns the role of theological disciplines such as Old and New Testament, Missiology and Systematic Theology and Practical Theology, and specifically the relationship between academic disciplines and societal growth. The book focuses on these challenges and contains the intellectual undertakings of the contributors who are all lecturers, research fellows and post-graduate students linked to the faculty.

The questions
The key questions addressed are: what are the contours of the (post)apartheid condition and what are the implications for responsible discipline practices in theology. Professor Venter says the chapters in the book are logically arranged and moves from wider to more specific concerns. The first three chapters suggest broad perspectives on the challenges for theology in higher education, chart the changes, and make some suggestions for the future.

A dynamic field of study
The book states that theology has already experienced profound and radical changes over the past decade, which is known to us. All the chapters demonstrate these fundamental shifts, which have taken place in all theological sub-disciplines. Professor Venter says the contributions in the book illustrate that theology is a dynamic field of study, and is pursued with enthusiasm and commitment. Not all disciplines in theology are investigated for the book. However, the studies reflect the interests of the theologians in the Faculty of Theology at the UFS. Professor Venter hopes that the volume might stimulate further reflection of a similar nature by other theologians.

New insights
Through the ‘UFS Theological Exploration’ research series, the faculty hopes to stimulate new insights and new developments in academic progress and overall human growth. Series editor Professor Francois Tolmie says it is a fact that strong university research is necessary to achieve academic progress and advance human prospering. He says the faculty's research series will make a valuable contribution to these causes. Professor Tolmie says the ‘UFS Theological Explorations’ contains research of the highest academic standard which has been peer-reviewed to make significant educational contributions to core theological issues in South Africa and overseas.

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