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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

Department of Agricultural Economics and agri-business join forces
2009-12-01

Some of the guests who attended the Department of Agricultural Economics' half-century celebration dinner were, from the left: Ms Chrisna van Heerden from Cape Wools; Mr Gielie Swart from Corporate Guarantee; Mr Jaco Heckroodt from VKB (Vrystaat Koöperasie Beperk) in Reitz; Mr Arno van Vuuren from NWK Beperk (Noord-Wes Koöperasie); Prof. Johan Willemse, Departmental Chairperson of the Department of Agricultural Economics at the UFS; and Ms Marcine Morsavel from GWK Beperk (Griekwaland-Wes Koöperasie).
Photo: Stephen Collett

The Department of Agricultural Economics at the University of the Free State (UFS) launched a bursary programme to support students studying Agricultural Economics during its recent half-centenary celebrations.

More than half a million Rands were collected from various agri-businesses at this prestigious event in order to support approximately 16 Agricultural Economics students from 2010 onwards.

“The Department is proud of the past 50 years’ training of students for agriculture in the fields of research, governance, banking and the agri-business environment and we have launched the bursary programme in order to position the University closer to agri-businesses,” said Prof. Johan Willemse, Departmental Chairperson of the Department of Agricultural Economics at the UFS.

The agri-businesses, who will act as sponsors, also benefit from the project, because they are afforded the opportunity to identify promising Agricultural Economics students as potential employees and to expose them to the activities of the businesses by means of holiday work. Upon completion of his/her studies, the student will already be fairly familiar with the circumstances of the specific agri-business and loyalty towards the business will already have been established.

Students who major in Agricultural Economics may apply for the bursary programme.

Agri-businesses that have already agreed to act as sponsors are Omnia Fertilizer, Pioneer Foods Pty, Suid-Wes Koöperasie Beperk, Corporate Guarantee, GWK Beperk (Griekwaland-Wes Koöperasie), VKB (Vrystaat Koöperasie Beperk), the National Woolgrowers Association and NWK Beperk (Noord-Wes Koöperasie).

More information can be obtained by phoning Ms Marie Engelbrecht on 051 401 9054.

Media Release
Issued by: Lacea Loader
Assistant Director: Media Liaison
Tel: 051 401 2584
Cell: 083 645 2454
E-mail: loaderl.stg@ufs.ac.za
1 December 2009

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