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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

The launch of a unique conservation project
2011-06-06

 

Our Department of Animal, Wildlife and Grassland Sciences launched a very special pilot project at Woodland Hills Wildlife Estate in Bloemfontein on Friday 03 June 2011, which aims to eventually aid in the conservation and study of one of Africa’s most graceful animals.

The project aims to provide the scientific basis needed for making future decisions in the best interests of the giraffe in the Kgalagadi Transfrontier Park in the Northern Cape and involves collaring and monitoring the behaviour and movement of these animals via GPS.

Based on the public interest in the giraffe and the increased impact of the growing giraffe population on the vegetation in the area, SANParks has been considering the translocation of a number of Kgalagadi giraffe. Due to limited information regarding their adaptation success and potential impact on their new environment, thorough planning and subsequent monitoring of the species is required.

Mr Francois Deacon from our university decided to undertake a PhD study to address the existing challenges. This will be the first study of its kind, undertaken on giraffe.

He says he decided on this project because of his love for animals and conservation. “There are nine sub-species of giraffe and seven of these are already endangered. I want to involve people and make them aware of the plight of the animals and the need for conservation,” he said.

The project kicked off on Friday morning, with a group of students and curious nature-lovers tracking a herd of giraffe at Woodland Hills. The challenge laid in identifying one of the animals which could easily be collared with a GPS device, tranquilising it, and applying the device, without harming the animal.

After a young bull was identified, it was up to Dr Floris Coetzee, a veterinarian, to get close enough to the animal to tranquilise it, and to the group of students to catch it and hold it down. All this was done perfectly and the animal was fitted with its new collars. The collars were designed and made by Mr Martin Haupt, who gained extensive experience in the design of similar collars for other research studies.

Mr Deacon will spend the following two weeks personally monitoring the animal constantly, to ensure that the collars do not cause any discomfort or injury and to determine whether it should be removed or adapted.

It has taken Mr Deacon over a year to plan the collaring process and the associated study. He says the main challenges in the project are financial, since it will cost approximately R500 000 to run over five years.

Thus far he has been supported by Mr Pieter Malan of Woodland Hills, Mr Cas Kempff of Cas Kempff Consulting Engineers and Prof. Frans Swanepoel of the UFS’ Directorate of Research Development, all of whom have been benefactors of the project.
Information gathered from the pilot project will provide the data to assess how to best fit the collar onto the giraffe to ensure that the animal is comfortable and that the collar will last in the wild.  Scientific data will be generated and processed for use by the Woodland Hills Wildlife Estate management.

Should the pilot project be successful, between four and eight giraffe in the Kgalagadi will be tracked using the satellite GPS collars. The GPS collars will enable the constant recording of the location of individual giraffe for up to 2 years. This will allow control and monitoring of the animals in real-time.

The main benefits of the project include, amongst others, improved decision-making, informing tourism development, education and community involvement, improved sustainability and improved cross-border collaboration between South Africa and Botswana.

Anyone who wishes to get involved with the project or get more information, should contact Me. Sonja Buhrmann at sbuhrmann@vodamail.co.za or 0827735768.
 

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