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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

UFS physicists publish in prestigious Nature journal
2017-10-16

Description: Boyden Observatory gravitational wave event Tags: Boyden Observatory, gravitational wave event, Dr Brian van Soelen, Hélène Szegedi, multi-wavelength astronomy 
Hélène Szegedi and Dr Brian van Soelen are scientists in the
Department of Physics at the University of the Free State.

Photo: Charl Devenish

In August 2017, the Boyden Observatory in Bloemfontein played a major role in obtaining optical observations of one of the biggest discoveries ever made in astrophysics: the detection of an electromagnetic counterpart to a gravitational wave event.
 
An article reporting on this discovery will appear in the prestigious science journal, Nature, in October 2017. Co-authors of the article, Dr Brian van Soelen and Hélène Szegedi, are from the Department of Physics at the University of the Free State (UFS). Both Dr Van Soelen and Szegedi are researching multi-wavelength astronomy.
 
Discovery is the beginning of a new epoch in astronomy
 
Dr van Soelen said: “These observations and this discovery are the beginning of a new epoch in astronomy. We are now able to not only undertake multi-wavelength observations over the whole electromagnetic spectrum (radio up to gamma-rays) but have now been able to observe the same source in both electromagnetic and gravitational waves.”
 
Until recently it was only possible to observe the universe using light obtained from astronomical sources. This all changed in February 2016 when LIGO (Laser Interferometer Gravitational-Wave Observatory) stated that for the first time they had detected gravitational waves on 14 September 2015 from the merger of two black holes. Since then, LIGO has announced the detection of two more such mergers. A fourth was just reported (27 September 2017), which was the first detected by both LIGO and Virgo. However, despite the huge amount of energy released in these processes, none of this is detectable as radiation in any part of the electromagnetic spectrum. Since the first LIGO detection astronomers have been searching for possible electromagnetic counterparts to gravitational wave detections. 
 
Large international collaboration of astronomers rushed to observe source
 
On 17 August 2017 LIGO and Virgo detected the first ever gravitational waves resulting from the merger of two neutron stars. Neutron star mergers produce massive explosions called kilonovae which will produce a specific electromagnetic signature. After the detection of the gravitational wave, telescopes around the world started searching for the optical counterpart, and it was discovered to be located in an elliptical galaxy, NGC4993, 130 million light years away. A large international collaboration of astronomers, including Dr Van Soelen and Szegedi, rushed to observe this source.
 
At the Boyden Observatory, Dr Van Soelen and Szegedi used the Boyden 1.5-m optical telescope to observe the source in the early evening, from 18 to 21 August. The observations obtained at Boyden Observatory, combined with observations from telescopes in Chile and Hawaii, confirmed that this was the first-ever detection of an electromagnetic counterpart to a gravitational wave event. Combined with the detection of gamma-rays with the Fermi-LAT telescope, this also confirms that neutron star mergers are responsible for short gamma-ray bursts.  
 
The results from these optical observations are reported in A kilonova as the electromagnetic counterpart to a gravitational-wave source published in Nature in October 2017.
 
“Our paper is one of a few that will be submitted by different groups that will report on this discovery, including a large LIGO-Virgo paper summarising all observations. The main results from our paper were obtained through the New Technology Telescope, the GROND system, and the Pan-STARRS system. The Boyden observations helped to obtain extra observations during the first 72 hours which showed that the light of the source decreased much quicker than was expected for supernova, classifying this source as a kilonova,” Dr Van Soelen said.

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