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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 mourns the death of a former Rector
2008-06-23



Photo: Prof. Wynand Mouton, last year during the launch of the UFS's Centenary Book.
 

It is with great sadness that the management of the University of the Free State (UFS) heard of the death of Prof. Wynand Mouton (79), former Rector of the UFS.

Prof. Mouton passed away this weekend in the Ferncrest Hospital in Rustenburg as a result of a cardiac arrest. He was visiting his son, Dr Wynand Mouton in Rustenburg when he fell ill three weeks ago and was admitted to hospital. Prof. Mouton’s wife, Daleen, passed away in April this year.

Prof. Mouton was Rector of the UFS from 1976-1988. His ties with the UFS stretch over 60 years. He studied for the B.Sc. degree at the UFS in 1948 and obtained doctorates in Physics and Nuclear Physics in 1960 and 1962, respectively, at the University of Utrecht.

Before his appointment as Rector of the UFS, Prof. Mouton was the first Vice-Rector of the University of Stellenbosch. He was jointly responsible for the establishment of the UFS Sasol Library and helped to stabilise the Development Trust Fund.

“Prof. Mouton left deep footprints at the UFS. He led the UFS to become a foremost research university in the country. Under his leadership, extensive sports fields were also developed on the west campus, including Shimla Park. He enlarged the university’s art collection and saw to it that student productions were staged in a modern, well-equipped theatre (later named after him),” says Prof. Teuns Verschoor, Acting Rector of the UFS.

“I am glad that we could honour him for this and other valuable contributions in 2004 with a Centenary Medal before he passed away,” says Prof. Verschoor.

Prof. Mouton was Chairman of the UFS Council from 1991-1996 and Chancellor of the UFS from 1996-1999. In 1995 he received an honorary doctorate from the UFS.

“Our sympathies go to Prof. Mouton’s children, Wynand, Hendrik and Ms Saretha Curry, as well as his three grandchildren,” says Prof. Verschoor.

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
23 June 2008

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