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

UFS chemist invited by UNESCO to present lecture at World Science Forum in Budapest
2015-12-07

From the left are: Dr Jean-Paul Ngome Abiaga from UNESCO, France; Abdoulaye Ibrahim, also from UNESCO in France; and Truidie Venter, a young scientist from the Department of Chemistry at the UFS.
Photo: Supplied

Dr Truidie Venter, a young scientist from Inorganic Chemistry in the Department of Chemistry at the University of the Free State (UFS), returned recently from presenting a lecture at the 7th World Science Forum, held in Budapest, Hungary. She was one of the few young researchers world-wide who were invited to attend the forum.

In her capacity as a young female researcher from Africa, Truidie was invited by UNESCO to present her views on science in diplomacy at this event. Her talk focused on collaboration between researchers from different countries, and the challenges faced by young researchers in Africa, and served to initiate discussions between young researchers concerning international, interdisciplinary scientific cooperation.

The Science Forum, an international conference dedicated to science and knowledge, was held in Budapest from 4-7 November 2015. This interdisciplinary gathering is supported by the United Nations Educational, Scientific and Cultural Organization (UNESCO), the International Council for Science (ICSU), and other partners, and is aimed at providing an occasion for representatives of science, politics, international organisations, industrial and financial decision makers, international science forums, and science academies to meet and exchange views.

More than nine hundred delegates from 108 countries took part in this event. The speakers included Her Royal Majesty Princess Sumaya Bint El Hassan, President of the Royal Scientific Society of Jordan, Dr Irina Bokova, the Director-General of UNESCO, Prof Sir Peter Gluckman, first Chief Science Advisor to the Prime Minister of New Zealand, Prof Ene Ergma, former President of the Riigikogu (Estonian Parliament), and Ms Naledi Pandor, Minister of Science and Technology of South Africa.

At the conclusion of the forum, a declaration was accepted regarding the renewal of the scientific community’s commitment to the responsible and ethical use of scientific knowledge in addressing the grand challenges of humankind. This declaration addressed the headings of climate change, new sustainable development paths, disaster risk reduction, scientific advice for policies, international collaboration for capacity-building and mobilisation in the developing world, and balanced investment in science.

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