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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

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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