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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

UFS Prestige Scholar shares her vision on crystallography with worldwide audience
2014-04-24

 
Dr Alice Brink
Dr Alice Brink, a Prestige Scholar and lecturer in the Department of Chemistry at the University of the Free State, was selected by UNESCO to participate, together with some 15 other young scientists from all over the world, in a round-table discussion at the Opening Ceremony of the International Year of Crystallography.

During this event, that took place in Paris, France, Dr Brink could, on stage, share her vision as one of the next generation of scientists.

“The 15 crystallographers consisted of eight young, established scientists and seven ‘young-young’ scientists who are starting their careers. We participated in a group discussion in order for the crystallographic community to better understand the challenges faced by young scientists across the globe.

“It was a great privilege to be invited to be part of this talented and diverse discussion group and to hear the challenges that are faced by young scientists from different parts of the world. It is also comforting to hear that scientific difficulties that are found in South Africa are commonly experienced in both First and Third World countries,” said Dr Brink.

“Crystallography has directly influenced the development of numerous scientific fields such as chemistry, physics, mathematics, medicine, engineering and material sciences. More inter-departmental collaboration would benefit greatly from crystallography, as this multi-faceted science provides foundation principles for applied research,” she said.

The United Nations declared 2014 as the International Year of Crystallography, and it was officially opened at the UNESCO Headquarters in Paris by the Secretary-General of the UN, Ban Ki-moon.

The ceremony was video-streamed live to more than 500 destinations all over the world.

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