Latest News Archive

Please select Category, Year, and then Month to display items
Years
2017 2018 2019 2020
Previous Archive
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 best black and white learners must come and study here
2009-09-17

 
At the meeting, arranged by the Faculty of Economic and Management Sciences, were from the left: Mr Tshdiso Makoelle, Clocolan High School; Mr Braam van Wyk, St Michael's School in Bloemfontein; Prof. Jonathan Jansen, Rector and Vice-Chancellor of the University of the Free State (UFS); Mr Izak Coetzee, Dr Blok Secondary School in Bloemfontein and Mr Okkie Botha, Witteberg High School in Bethlehem.
Photo: Stephen Collett
 “I want to make this university one of the best universities in the country and in the world. For this I will need the support of principals and teachers.” These were the words of Prof. Jonathan Jansen, Rector and Vice-Chancellor of the University of the Free State (UFS) during a recent meeting with school principals held on the Main Campus in Bloemfontein, which was arranged by the Faculty of Economic and Management Sciences.

“I want the best black and white learners to come and study here and therefore I am going to visit schools in the region to find out how we can attract the best learners,” he said.
The most important influence on learners is their teachers and principal. “This why I need the support of teachers and principals to guide their learners to come and study here,” said Prof. Jansen.

Prof. Jansen said that it was of no use to work with Grade 11 and 12 learners only as it was mostly too late to change their minds. He wants to work with Grade 10 learners and make them excited about university life so that they will know what the UFS can offer them. He will also visit poor and rural schools and tell them about the UFS.

“When a Kovsie graduate walks down the street something must distinguish him/her from other graduates. Our graduates must be able to work anywhere in the world,” he said.

“Students must have the ability to live with other people and to be comfortable around people who look and speak differently than them. I want our students to be multi-lingual and to be comfortable around other students and people in terms of religion, race, language, etc. Students who do not have this added value will not be successful in the market,” he said.

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

We use cookies to make interactions with our websites and services easy and meaningful. To better understand how they are used, read more about the UFS cookie policy. By continuing to use this site you are giving us your consent to do this.

Accept