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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

Researchers international leaders in satellite tracking in the wildlife environment
2015-05-29

 

Ground-breaking research has attracted international media attention to Francois Deacon, lecturer and researcher in the Department Animal, Wildlife and Grassland Sciences at the UFS, and Prof Nico Smit, from the same department. They are the first researchers in the world to equip giraffes with GPS collars, and to conduct research on this initiative. Recently, they have been joined by Hennie Butler from the Department of Zoology as well as Free State Nature Conservation to further this research.

“Satellite tracking is proving to be extremely valuable in the wildlife environment. The unit is based on a mobile global two-way communication platform, utilising two-way data satellite communication, complete with GPS systems.

“It allows us to track animals day and night, while we monitor their movements remotely from the computer. These systems make possible the efficient control and monitoring of wildlife in all weather conditions and in near-to-real time. We can even communicate with the animals, calling up their positions or changing the tracking schedules.

“The satellite collar allows us to use the extremely accurate data to conduct research with the best technology available. The volume of data received allows us to publish the data in scientific journals and research-related articles.  

“Scientific institutions and the public sector have both shown great interest in satellite tracking, which opens up new ground for scientific research for this university. Data management can be done, using Africa Wildlife Tracking (AWT) equipment where we can access our data personally, store it, and make visual presentations. The AWT system and software architecture provide the researcher with asset tracking, GPS location reports, geo-fencing, highly-detailed custom mapping, history reports and playback, polling on demand, history plotting on maps, and a range of reporting types and functions,” Francois said.

Data can be analysed to determine home range, dispersal, or habitat preference for any specific species.

Francois has been involved in multiple research projects over the last 12 years on wildlife species and domesticated animals, including the collaring of species such as Black-backed Jackal, Caracal, African Wild Dog, Hyena, Lion, Cheetah, Cattle, Kudu, Giraffe, and Black Rhino: “Giraffe definitely being the most challenging of all,” he said.

In 2010, he started working on his PhD, entitled The spatial ecology, habitat preferences and diet selection of giraffe (Giraffa camelopardalis giraffa) in the Kalahari region of South Africa.

 

Since then, his work has resulted not only in more research work (supervising four Masters students) but also in a number of national and international projects. These include work in the:

  • Kalahari region (e.g. Khamab Nature Reserve and Kgalagadi Transfrontier Park)
  • Kuruman region (Collared 18 cattle to identify spatial patterns in relation to the qualities of vegetation and soil-types available. This project took place in collaboration with Born University in Germany)
  • Woodland Hills Wildlife Estate and Kolomella Iron Ore – ecological monitoring
  • A number of Free State nature reserves (e.g. Distribution of herbivores (kudu and giraffe) and predators (camera traps)

Francois is also involved with species breeding programmes and management (giraffe, buffalo, sable, roan, and rhino) in Korrannaberg, Rustenburg, Hertzogville, Douglas, and Bethlehem as well as animal and ecological monitoring in Kolomella and Beesthoek iron ore.

Besides the collaring of giraffes, Francois and his colleagues are involved in national projects, where they collect milk from lactating giraffes and DNA material, blood samples, and ecto/endo parasites from giraffes in Southern Africa.

With international projects, Francois is working to collect DNA material for the classification of the nine sub-species of giraffe in Africa. He is also involved in projects focusing on the spatial ecology and adaptation of giraffe in Uganda (Murchison Falls), and to save the last 30 giraffe in the DRC- Garamba National Park.

This project has attracted a good deal of international interest. In June 2014, a US film crew (freelancing for Discovery Channel) filmed a documentary on Francois’ research (trailer of documentary). Early in 2015, a second crew, filming for National Geographic, also visited Francois to document his work.

 

More information about Francois’ work is available at the GCF website. 

Read Francois Deacon's PhD abstract

Direct enquiries to news@ufs.ac.za.

 

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