Latest News Archive

Please select Category, Year, and then Month to display items
Years
2017 2018 2019 2020
Previous Archive
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

NRF grants of millions for Kovsie professors
2013-05-20

 

Prof Martin Ntwaeaborwa (left) and Prof Bennie Viljoen
20 May 2013


Two professors received research grants from the National Research Foundation (NRF). The money will be used for the purchase of equipment to add more value to their research and take the university further in specific research fields.

Prof Martin Ntwaeaborwa from the Department of Physics has received a R10 million award, following a successful application to the National Nanotechnology Equipment Programme (NNEP) of the NRF for a high-resolution field emission scanning electron microscope (SEM) with integrated cathodoluminescence (CL) and energy dispersive X-ray spectrometers (EDS).

Prof Bennie Viljoen from the Department of Microbial, Biochemical and Food Biotechnology has also been awarded R1,171 million, following a successful application to the Research Infrastructure Support Programme (RISP) for the purchase of a LECO CHN628 Series Elemental Analyser with a Sulphur add-on module.

Prof Ntwaeaborwa says the SEM-CL-EDS’ state-of-the art equipment combines three different techniques in one and it is capable of analysing a variety of materials ranging from bulk to individual nanoparticles. This combination is the first of its kind in Africa. This equipment is specifically designed for nanotechnology and can analyse particles as small as 5nm in diameter, a scale which the old tungsten SEM at the Centre of Microscopy cannot achieve.

The equipment will be used to simultaneously analyse the shapes and sizes of submicron particles, chemical composition and cathodoluminescence properties of materials. The SEM-CL-EDS is a multi-user facility and it will be used for multi- and interdisciplinary research involving physics, chemistry, materials science, life sciences and geological sciences. It will be housed at the Centre of Microscopy.
“I have no doubt that this equipment is going to give our university a great leap forward in research in the fields of electron microscopy and cathodoluminescence,” Prof Ntwaeaborwa said.

Prof Viljoen says the analyser is used to determine nitrogen, carbon/nitrogen, and carbon/hydrogen/nitrogen in organic matrices. The instrument utilises a combustion technique and provides a result within 4,5 minutes for all the elements being determined. In addition to the above, the machine also offers a sulphur add-on module which provides sulphur analysis for any element combination. The CHN 628 S module is specifically designed to determine the sulphur content in a wide variety of organic materials such as coal and fuel oils, as well as some inorganic materials such as soil, cement and limestone.

The necessity of environmental protection has stimulated the development of various methods, allowing the determination of different pollutants in the natural environment, including methods for determining inorganic nitrogen ions, carbon and sulphur. Many of the methods used so far have proven insufficiently sensitive, selective or inaccurate. The availability of the LECO analyser in a research programme on environmental pollution/ food security will facilitate accurate and rapid quantification of these elements. Ions in water, waste water, air, food products and other complex matrix samples have become a major problem and studies are showing that these pollutants are likely to cause severe declines in native plant communities and eventually food security.

“With the addition of the analyser, we will be able to identify these polluted areas, including air, water and land pollution, in an attempt to enhance food security,” Viljoen said. “Excess levels of nitrogen and phosphorous wreaking havoc on human health and food security, will be investigated.”

We use cookies to make interactions with our websites and services easy and meaningful. To better understand how they are used, read more about the UFS cookie policy. By continuing to use this site you are giving us your consent to do this.

Accept