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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

Record number of students to graduate at UFS
2017-06-19

Description: Day 2 Mid-year Graduation Bloemfontein Campus Tags: Day 2 Mid-year Graduation Bloemfontein Campus

Eleven graduation ceremonies will form part of the
mid-year graduation ceremonies at the
University of the Free State.
Photo: Charl Devenish

Livestream of Graduation Ceremonies

Six days, eleven ceremonies, and more than 5 000 degrees. This all forms part of what is the biggest set of graduation ceremonies in the history of the University of the Free State (UFS).

The mid-year graduation ceremonies, taking place from 19 to 26 June 2017 in the Callie Human Centre on the Bloemfontein Campus, will see the most students graduate during a week. A total of 5 258 degrees, which includes 460 master’s and doctoral degrees, will be conferred – including 72 doctoral degrees.

First graduation ceremonies for Prof Petersen
It will also be the first ceremonies that Prof Francis Petersen, new Rector and Vice-Chancellor, attends on the Bloemfontein Campus. Students from all seven faculties, as well as the South Campus, will graduate.

Graduates per faculty are (without master’s and doctoral degrees): Faculty of Education (488), Faculty of Health Sciences (345), Faculty of Theology (29), Faculty of Law (686), Faculty of Natural and Agricultural Sciences (1 029), Faculty of Economic and Management Sciences (1 044), Faculty of the Humanities (826), and the South Campus (354).

Guest speakers include three judges
Guest speakers for the ceremonies include Dipiloane Phutsisi, Principal and Chief Executive Officer of the Motheo TVET College in the Free State, Dr Susan Vosloo, UFS Council member and founder member of the World Society for Paediatric and Congenital Heart Surgery, and Prof Petersen.

Three judges will also act as speakers. They are Justice Ian van der Merwe, Judge of Appeal at the Supreme Court of Appeal and former Chair of the UFS Council, Justice Mahube Molemela, Judge President of the Free State Division of the High Court and Acting Justice of the Supreme Court of South Africa, and Justice Connie Mocumie, Judge of Appeal at the Supreme Court of Appeal.

Graduations ceremonies:

19 June 2017:
09:00: Faculty of Education, except educational qualifications in Open Distance Learning –  South Campus
14:30: Faculty of Health Sciences, Faculty of Theology and Faculty of Law (including the School of Financial Planning Law)

20 June 2017:
09:00: Faculty of Natural and Agricultural Sciences: All Bachelor’s degrees
14:30: Faculty of Natural and Agricultural Sciences: All Diplomas and Bachelor Honours degrees

21 June 2017:
09:00: Faculty of Economic and Management Sciences: All Certificates, Diplomas, Bachelor’s degrees and Bachelor Honours degrees, excluding BCom degrees
14:30: Faculty of the Humanities: Social Sciences and Communication Sciences only

22 June 2017:
09:00: Faculty of Economic and Management Sciences: BCom degrees only
14:30: Faculty of the Humanities: All qualifications except Social Sciences and Communication Sciences

23 June 2017:
14:30: Educational qualifications in Open Distance Learning – South Campus

26 June 2017:
09:00: All faculties except the Faculty of Natural and Agricultural Sciences: Master’s and Doctoral degrees
14:30: Faculty of Natural and Agricultural Sciences: Master’s and Doctoral degrees


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