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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

Centre for Human Rights at UFS geared to make impact in the region
2017-03-02

Description: Centre for Human Rights  Tags: Centre for Human Rights

SAHRC situated in the Mabaleng building,
Bloemfontein Campus
Photo: Hannes Pieterse

After approval by the Rectorate, Senate and Council of the University of the Free State (UFS), the Free State Centre for Human Rights (FSCHR) began operations on 1 January 2016 on the Bloemfontein Campus, under the leadership of Prof Leon Wessels, founding member of the South African Human Rights Commission (SAHRC) as the Acting Director of the centre.

Human rights remain, undoubtedly, the dominant moral and political language of our times and thus demands multi-layered scholarly engagement as it influences national and international relations, and sets standards for political and democratic practice.

Establishment of centre fulfilment of court order
Top on the centre’s agenda will be to resolve the debate with the SAHRC relating to the February 2011 post-Reitz agreement of the UFS, which was subsequently made an order of the Equality Court. This order compelled the UFS to establish such a centre. The FSCHR presents new opportunities for cooperation between the FSCHR, the SAHRC and other stakeholders to the benefit of the UFS and the broader community.

Three divisions of the centre to achieve its mandate
The centre consists of three inter-related divisions with the potential to stimulate critical scholarship in the field of human rights through its postgraduate and research division. This is reflected in the centre’s mission to deepen the study of human rights and further its praxes by developing novel methodologies in which traditional human rights issues can be complemented by interdisciplinary and multi-disciplinary approaches.

The Advocacy division of the centre will promote human rights among UFS staff and students, and the surrounding community. The aim is to establish a vibrant human rights culture in and across all campuses in which rights of all are respected and protected.

The Legal Services division will provide trustworthy legal services to individuals and groups whose fundamental rights have been abused, to improve the professional capacity of paralegals, students, counsellors, social workers, candidate attorneys and attorneys, equipping them to deal with cases of infringement of constitutional and human rights and to increase access to justice to rural and indigent communities in the Free State.

Centre key in positioning UFS as a regional leader in human rights issues
The centre, with its inter- and multi-disciplinary approach, has the potential to become one of the flagship projects of the UFS, and will strengthen both the Academic and Human Projects. A UFS human rights centre not only makes sound scholarly and practical sense, it also has limitless symbolic value. The location of one of UFS’s campuses within the city of Bloemfontein (the judicial capital of South Africa) and having partnered with the National University of Lesotho (NUL), is historically and geographically significant. This has a great impact on the UFS, the Free State province as a whole, and the Kingdom of Lesotho.  

The FSCHR will be officially launched on 14 March 2017 with Professor Bongani Majola, newly elected chairperson of the SAHRC, as guest speaker.

For further information on the work of the centre, please contact FSCHR@ufs.ac.za / +27 51 401 7216.

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