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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

Harvard couple to present lectures on Biostatistics and Mathematics at the UFS
2015-12-07


Professor Donald Rubin

Prof Donald Rubin (John L. Loeb Professor of Statistics at Harvard University) and Elizabeth Zell (MStat - mathematical statistician in the Division of Bacterial Diseases) will visit the University of the Free State (UFS) where they will present lectures on their respective work.

Over his prestigious academic career, Prof Don Rubin’s 400 publications and 13 books have earned him around 180 000 citations at an h-index of 113. He is one of the most cited statisticians/mathematicians/economists/psychologists in the world over the last 10 -15 years. He has supervised 35 PhD candidates as sole-supervisor, 17 more as co-supervisor, with a further eight in the pipeline.

Prof Rubin who will meet with UFS academics in the Department of Mathematics and Actuarial Sciences will also deliver a lecture: Rerandomisation to improve covariate balance in experiments.

Randomised experiments are the “gold standard” for estimating causal effects, yet in practice, chance imbalances often exist in covariate distributions between treatment groups. If covariate data are available before units are exposed to treatments, these chance imbalances can be mitigated by first checking covariate balance before the physical experiment takes place. Provided a precise definition of imbalance has been specified in advance, unbalanced randomisations can be discarded, followed by a rerandomisation. This process can continue until a randomisation yielding balance according to the definition is achieved. By improving covariate balance, rerandomisation provides more precise and trustworthy estimates of treatment effects.

Prof Rubin received an honorary professorship from the Faculty of Natural and Agricultural Sciences at the UFS.


Elizabeth Zell

The lecture will take place on:
Date: Tuesday 8 December 2015
Time: 16:00
Venue: Albert Wessels Auditorium, Bloemfontein Campus

Zell earned her Master’s degree in Statistics at North Carolina State University, and for more than two decades, was an active bio-statistical researcher in various offices of the Centers for Disease Control (CDC). Since 2013, she has been the Principal Statistician and President of Stat-Epi Associates, Inc. Her 150+ publications have earned her 14 500 citations at an h-index of over 50. She is a Fellow of the American Statistical Association, and, in 2010, she received the Statistics Section Government Award for outstanding contributions to statistics and public health by the American Public Health Association. During her career at the CDC, she earned more than 20 CDC research awards and honours.

She will deliver two lectures at the UFS. The first is entitled A Potential Outcomes Approach to Documenting the Public Health Impact of the Introduction of PCV13 for the Prevention of Invasive Pneumococcal Disease. The topic of her second lecture is: Assessing the Effectiveness of Intrapartum Antibiotic Prophylaxis for Prevention of Early-Onset Group B Streptococcus Disease through Propensity Score Design

Elizabeth’s lectures will take place on:
Date: Wednesday 9 December 2015
Time: 10:45 and 13:00
Venue: West Block 111, Bloemfontein Campus

For more information, please contact Dr Michael von Maltitz at VMaltitzMJ@ufs.ac.za.

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