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

Unique partnership flows out of our Schools Projects
2011-06-29

 

 At the meeting between our university and principals and teachers of three of the 23 schools in our university’s Schools Partnership Project were, from the left: Mr Motlolometsi Tshidiso,  Tsotseletso Secondary School; Dr Choice Makhetha, Vice-Rector: External Relations (acting); Mr Vuyo Mlinde, Bloem-Oos Intermediary School; back: Dr Peet Venter, Head of our South Campus, and Mr Tlhabedi Mafoyane from Kagisho Secondary School.

Our university established a unique partnership flowing from two of its community initiatives; the UFS Schools Partnership Project and the Extreme Make-over for Schools Project. Bloem-Oos Intermediary School which will benefit from the Extreme Make-over for Schools Project formed a partnership with Kagisho and Tsotseletso Secondary schools becoming a feeder school for the two schools. Both Kagisho and Tsotseletso Secondary schools are now beneficiaries of the UFS Schools Partnership Project.

With the Schools Partnership Project, the university is working closely with the 23 schools for a three- to five-year-period to help schools to become top achievers of which the teachers, learners and parents could be proud. The schools were identified last year and the groundwork for this project was finalised in 2010 as well. The university’s involvement in the Extreme Make-over for Schools Project includes amongst others a partnership with the Department of Basic Education and the Bloemfontein business community to work together to launch the first of a number of a newly upgraded schools to learners, teachers and the community. Bloem-Oos Intermediary School became the first school in Bloemfontein to undergo an extreme makeover.
 
Management structures from the University, including Prof. Jonathan Jansen, Vice-Chancellor and Rector, Dr Choice Makhetha, Vice-Rector: External Relations (acting), and Dr Peet Venter, Campus Head of the our South Campus, recently met with the principals and some of the teachers of three schools that form part of these two community initiatives of the university. The meeting between the university and principles Mr Tlhabedi Mafoyane (from Kagisho Secondary School), Mr Motlolometsi Tshidiso (Tsotseletso Secondary School) and Mr Vuyo Mlinde (Bloem-Oos Intermediary School) took place to enhance the relationships between the parties involved.
 
Dr Makhetha said, “When you support a school you groom learners to fit into the culture of the university. We were excited to learn that Bloem-Oos Intermediary School is a feeder school for Kagisho and Tsotseletso Secondary Schools. This partnership allows us to not only prepare learners already from an early age for university but also throughout their high school career. Let us make this project a model for South Africa.”
 
Continuous efforts and projects from the university as well as partners in the community, to invest in the learners of Bloem-Oos Intermediary School, include:
-       The Project for Peace: A calculator project where learners will be taught on how to use a scientific calculator properly. A group of the learners will also be supplied with a free calculator.
-       The Music Project: The Odeion School of Music at the UFS will also bring a music programme to the school.
-       The Desk Project: This project includes fixing of all broken desks by Group 4 Correctional Facility. (This initiative includes all the broken desks of all the 23 schools in involve in the UFS Schools Partnership Project.)
 

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