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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

Prof Hendrik Swart richly contributes to research of phosphors
2014-12-02

Prof Hendrik Swart
Photo: Merwelene van der Merwe

Since his appointment as the South African Research Chairs Initiative (SARChI) Chair, there has been a sharp increase in the number of papers and publications by Prof Hendrik Swart, Senior Professor in the Department of Physics at the University of the Free State (UFS). From January this year, he has already published 78 articles. Some of the journals that has published his work, includes:

• Nanotechnology (impact of 3.67)
• Dalton Transactions (impact of 4.097)
• Sensors and Actuators B: Chemical (impact 3.84)

“My biggest success, however, is the powerful group of researchers we have built over the years. Staff, postdocs and students – without them it would have been impossible. I am therefore much indebted to my groups on both the Bloemfontein and Qwaqwa Campuses.

“The good apparatus we acquired via a sponsorship from the National Research Foundation and Sasol is also one of the main reasons for this. The financial support I get from the university’s research office is of course also a contributing factor,” he says.

For the past 20 years, Prof Swart has been conducting research on any substance that glows. “I only adjust the focus to fit in with current trends,” he says.

Prof Swart believes that his research will make a contribution to the fundamental knowledge about phosphors, as well as to the training of good students for the academic and industrial world on the outside. For the man on the street, his research translates into better, brighter lights that use less energy.

His more recent research focuses on the development of nano-phosphors for light-emitting diodes (LEDS) and organic light-emitting diodes (OLED).

Prof Swart has presented papers on his research not only nationally, but all over the world – including countries in Europe and the East. Some of the most recent papers presented by him and his colleagues/postgraduate students include:

• Applications of AES, XPS and TOF SIMS to phosphor materials at die 15th European Conference on Applications of Surface and Interface Analysis 2013 in Forte Village Resort, Sardinia, Italy.
• Luminescent properties of phosphor nano thin films at the first International Symposium on Nanoparticles/Nanomaterials and Applications in Caparica (Lisbon, Portugal), where he was an invited speaker.
• Role of surface and deep-level defects on the emission of nano metal oxides at the 2014 NanoAfrica international conference, Vanderbijlpark, South Africa, where he delivered the keynote address.
• PHI systems and their modifications at KOVSIES at the PHI European User Meeting in Ismaning (Munich), Germany, where he was invited to speak.

Prof Swart also delivered the keynote address at the SETCOR International Conference on Smart Materials and Surfaces in Bangkok, Thailand. His lecture was titled, ‘Role of surface and deep-level defects on the emission and degradation of phosphor materials’.

 

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