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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

Kovsie trailblazing track runner sets South African 200 m record
2015-07-16

Photo: IAAF

Wayde van Niekerk became the only South African, and the fourth athlete in the world, to clock sub-20-seconds in a 200 m race on Tuesday 14 July 2015. With this winning time, he became the fourth member of the prestigious quartet, consisting of Michael Johnson, LaShawn Merritt, Isaac Makwala and himself.

The Kovsie gold medallist’s ground-breaking performance saw him beat world-class 200 m specialist and last year's Diamond League race winner, Alonso Edward of Panama.  Van Niekerk crossed the finish line half a metre ahead of Edward, who was followed by Fujmitsu Kenji of Japan in the third place.

Van Niekerk's 19.94-time at the Diamond League meeting in Lucerne (Switzerland) set a national record, and improved on his personal best. In 2010, he claimed the World Junior Championship title in Moncton, Canada, by covering 200 m in 21.02 seconds.

Recently, he made history by defeating the London 2012 Olympic Games champion, Kirani James, of Grenada in the Caribbean.

On 4 July 2015, he surged 0.79 seconds ahead of Kirani in his number five lane, becoming the first African to cover 400m in less than 44 seconds. The Kovsie student won the race at 43.96, occupying 10th place on the International Association of Athletics Federations (IAAF) Diamond League all-time list.

Kovsies were still celebrating the gold medalist’s South African record-setting time of 44.24 on 13 June 2015 when he dominated the Diamond League meeting. At the previous race in New York, Van Niekerk improved on his own national record of 44.38. With an impressive dash to the finish line at that particular event, he surpassed Christopher Brown’s 400 m record.

In addition to the country’s record, Van Niekerk made his name as one of the continent’s record-breakers. On 7 June 2015, he broke the 1986 African 300 m record. Van Niekerk replaced Ivorian Gabriel Tiacoh’s best time of 31.74 with a 31.63 championship win at the Birmingham Diamond League meeting.  Simultaneously, he bettered Morné Nagel’s 2006 South African national record.

Following his outstanding performance, he was positioned in 10th place on the world list in the men’s 300 m.

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