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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

Internet Broadcast Project grabs attention of Commonwealth – and yet another award
2015-07-28


 
Learn more about the Internet Broadcast Project and its impact on learners’ lives

The Internet Broadcast Project (IBP) has brought yet another international award to the University of the Free State (UFS). This project – which is changing the lives of Free State school learners – has won second place in the Commonwealth Education Good Practice Awards, a huge achievement considering that the IBP was chosen from 89 submissions entered by a total of 20 countries belonging to the Commonwealth.

This latest award comes close on the heels of another international award that was presented to the IBP recently. In April 2015, the project was the winner of the 2015 Enterprise Video Award (EVA) in the category Video in Education Scholarship. This makes it two in a row, since the IBP also won an EVA in 2014 for Innovation in Pedagogy.

 

Mr Kamalesh Sharma, Secretary General of the Commonwealth Secretariat, presenting the second-place prize for the Commonwealth Good Practice Awards to Sarietjie Musgrave, Head: ICTISE (ICT in School Education) on behalf of ICTISE.
Photo: Peter Ramsay

Live broadcast at no cost to schools
The IBP – presented from the UFS South Campus – makes use of the best teachers to broadcast lessons to school learners who do not have access to quality education. More than 10 subjects are broadcast live, via VSAT Internet Access, to 70 centres across the province. The technology provided at each school allows learners to communicate with the presenter in the studio during broadcast at no cost to the school or learner.

“Through the IBP,” says Sarietjie Musgrave, Head: ICTISE (ICT in School Education), “we aim to bring quality education to each and every learner, regardless of their socio-economic status or geographical location, while delivering cost-effective continuous teacher professional development directly relevant to the Free State community we serve.”

Making a positive difference
The Commonwealth Education Good Practice Awards honour education programmes that have made a positive difference to the status and condition of school children, teachers, or the education system in their countries. The IBP was lauded for its excellence in six of the Action Areas of Good Practices:

• Relevance
• Measurable impact and effect
• Sustainability
• Efficiency and effectiveness
• Community participation
• Replication

“Receiving this international award,” says Musgrave, “shows that we are having an impact worldwide.”

 

 

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