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11 February 2021 Photo UFS photo archive
The National Control Laboratory for Biological Products (NCL) Building.

There can be no compromise when it comes to the quality of medicines made available to the public.

The UFS-based National Control Laboratory for Biological Products (NCL) is a full member of the international WHO-National Control Laboratory Network for Biologicals and one of 12 laboratories worldwide contracted to perform vaccine testing for the World Health Organisation (WHO). The NCL is also 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 the South African Health Products Regulatory Authority (SAHPRA).

In its role as a 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. 

International testing standards

The laboratory received the status of a pharmaceutical testing laboratory after the South African Accreditation System (SANAS) endorsed its quality-management systems as of a high standard according to the International Standards Organisation’s requirements.

With its international testing standards, the NCL must ensure that all its operations – 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.

The laboratory has all the quality systems in place to ensure high-quality test results. The certificate of Good Manufacturing Compliance received in 2019 indicates that laboratory testing is on the expected level for any pharmaceutical testing laboratory and manufacturer. This certification is very strict and means that the NCL complies with exceptionally strict standards for pharmaceutical labs anywhere in the world. The certification offers the South African Health Products Regulatory Authority, the WHO, and other national control laboratories around the world the confidence that the test results from the NCL can be trusted.

Licensed as pharmaceutical manufacturer

The laboratory is also licensed as a pharmaceutical manufacturer. Although the lab does not manufacture, it needs 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.

News Archive

Prestige scholar, Oliver Mutanga, to continue research at University of Pavia through CICOPS scholarship
2014-12-19

 

Oliver Mutanga has been awarded a 2015 CICOPS scholarship – one of only ten researchers world-wide to be afforded this opportunity. The scholarship enables Mutanga to visit the University of Pavia in Italy from January to March next year to expand his research.

As a second-year PhD student taking part in the Vice-Chancellor’s Prestige Scholars Programme, Mutanga is well on his way to achieve his goal of becoming an internationally-recognised scholar. He is currently conducting his research at our Centre for Research on Higher Education and Development under the supervision of Prof Melanie Walker and Dr Lis Lange. In his PhD, Mutanga examines the processes through which disabled students make their educational choices and negotiate different socio-cultural and institutional structures in higher education.

During his stay in Italy, Mutanga will work with Prof Enrica Chiappero-Martinetti on the intersectionality of disability, disadvantage and other social variables. “I will also present lectures and seminars on my PhD work at Pavia University and meet with other young capabilities approach scholars,” Mutanga says.

There is a growing acknowledgement nationally and internationally that there is limited data and understanding of the framing on disability issues. As such, data on the experiences of disabled students in higher education is important and timely in preparation of the Post 2015 Development Agenda.

Mutanga’s preliminary analysis challenges the popular discourse that is so common in South African higher education debates that they receive unprepared students into their institutions. The data seems to indicate the opposite, though: that it might be the institutions that are underprepared to receive diverse students. The study advocates for a capabilities-based conception of student equity that focuses on the widening of opportunities for all students within higher education to pursue what they have reason to value.

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