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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

Open Day engulfs Bloemfontein Campus with colour, crowds and cheer
2013-05-04

 

08 May 2013
Photo: Lelanie de Wet


   Open Day YouTube video

The procession – comprising of Prof Jonathan Jansen and the Deans of all the UFS faculties – stately entered a packed Callie Human Centre on Saturday morning 4 May 2013. As everyone took their seats, all the lights were abruptly cut, leaving the hall in a stunned silence. Suddenly brilliant beams of green, blue and red lights cut through the dark, exploding into a spectacular laser show.

Open Day 2013 on the Bloemfontein Campus was officially under way.

The audience of parents and prospective students were awe-struck by a transfixing electric guitar performance, dancers lit up by LED suits, pulsing music and finally Corneil Muller singing to the accompaniment of Prof Jansen behind the piano.

Vice-Chancellor and Rector, Prof Jansen immediately made attendees from across all nine provinces, Namibia, Lesotho and several other countries feel at home and embraced by the university. During his welcoming address, Prof Jansen referred to the fact that Kovsies places the bar high when it comes to achievement. “We expect more of our students,” he said. “Passing is not important, passing wéll is important.” He stressed that at the university we teach students to be decent, to be exceptional people. “We place a high premium on being an outstanding human being.” He went on to say that our students are better than the previous generation – they do not carry the baggage of the old.

Prof Jansen also communicated the university’s commitment to developing leaders with an understanding of the world. This is why the university afford students the opportunity, amongst other things, to study abroad. Students have access to a wide variety of organisations and the privilege to have access to leaders who they can converse with. Kovsies strives to produce leaders, not only in the community, but on a global platform.

To demonstrate this last point, top Kovsie achievers joined Prof Jansen on stage to relay their stories of perseverance, courage and success. Included among these stars, were athlete Danél Prinsloo; Varsity Cup Player that Rocks 2013 Oupa Mohoje; DW Bester, a Rhodes Scholar currently studying at Oxford University in the United Kingdom; and Jurie Swart, who ranked under the top five in the 2012 International Graduate Architecture Student Design competition.

The residences pulled out all stops when it came to the presentation of their individual stalls. The gardens in front of the Main Building burst with colour, sound, dancing and laughter as the residences competed to draw the most visitors. The faculties also opened their doors for a glimpse at the exciting opportunities awaiting prospective students.

A record amount of visitors went home with the words of Rudi Buys, Dean of Student Affairs, inscribed in their minds summing up what the UFS is all about: “Where a sense of community matters more than the colour of your skin.”

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