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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

Kovsies paint Bethlehem red!
2010-03-20

At the matric evening of the Secondary School Witteberg in Bethlehem were, from the left: Lebogang Motaung; Rozelle Venter; Prof. Jonathan Jansen, Rector and Vice-Chancellor of the UFS; Ernest Bezuidenhout; Donald Motaung; and Mr Rudi Buys, Dean of Student Affairs at the UFS.
Photo: Lynda Greyling


“The learners of the High School Witteberg are a wonderful example of the quality of students that we can expect as first years here at Kovsies next year,” Prof. Jonathan Jansen, Rector and Vice-Chancellor of the University of the Free State (UFS) said last night during a matric evening attended by 121 Grade 12 learners and their parents in a packed hall at the Secondary School Witteberg in Bethlehem.

Prof. Jansen and his wife Grace, as well as some of his colleagues were guests of honour at the event.

“We want to make a difference in the lives of our students at Kovsies and we want to ensure that our students make a difference in a divided world. This is why I want each Grade 12 learner who is here tonight to come and study at the UFS,” he told the learners and their parents.

“The UFS is going to become the university in the country that is serious about quality. We want to draw the best students. Quality entails hard work. It is about perseverance and your commitment towards your studies. That is the type of students we want.”

“My door is open to our students and they have access to come and talk to me. I also regularly sit at different places on the campus and then invite students to come and talk to me. I want our students to feel at home here.”

“I also want our students to feel free to talk about the use of language at the UFS. We love Afrikaans, English and Sesotho and are not going to fight about language. We are going to develop the use of Afrikaans so that more students can speak it – and this also goes for English and Sesotho.”

Prof. Jansen said that Kovsie students had to be balanced students. “Our students must also excel in sport, art, etc., because the development of students who are properly prepared for the workplace is what we strive for as a tertiary institution. Therefore we are going to establish an office that assists students in their career preparation and will offer students internships so that they can come into contact with leading firms in the commerce and industry sectors.”

“However, we shall also actively enhance our students’ learning experience and therefore we are going to send a group of first-year students overseas in the second semester this year to gain knowledge about issues like integration and collaboration.”

At the occasion Prof. Jansen announced that bursaries to study at the UFS in 2011 would be awarded to the two top Grade 12 learners of the school.

The Secondary School Witteberg had a 100% pass rate in the Grade 12 final examinations the past few years. In 2009 the school was seventh amongst the top 50 schools in the Free State Province. Five learners from the school were also amongst the top 20 learners in the Province last year. The school has already produced many top students for the UFS.

Mediaverklaring
Issued by: Lacea Loader
Director: Strategic Communication (acting)
Tel: 051 401 2584
Cell: 083 645 2454
E-mail: loaderl@ufs.ac.za  
18 March 2010
 

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