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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

“Breakthroughs depend on people believing in their own ideas”
2015-07-23


TED is a renowned international non-profit organisation dedicated to disseminating “ideas worth spreading” in the form compelling talks lasting up to 18 minutes.

Lerothodi Molete’s vision is to witness the youth of Bloemfontein emerge at the forefront of technological, scientific, and entrepreneurial innovations in both South Africa and the global arena.

 

Molete and Bonginkosi Leeuw are the organisers of TEDxUFS. Their duty is centered on inspiring people to believe in, and express, their ideas. These University of the Free State students have taken it upon themselves to inspire the youth to “push the boundaries of society.”

 

The second TEDxUFS event to be hosted by the university presents a unique opportunity for students, staff members, and the general public to mingle with influential speakers from across various disciplines.

 

Details of the event:

 

Date: Saturday 1 August 2015

Time: 08:00- 18:00

Venue: Albert Wessels Auditorium, Bloemfontein Campus

 

The keynote speakers include: Mmusi Maimane (Federal Leader: Democratic Alliance), Gareth Cliff (Radio personality: Cliff Central), Pieter Geldenhuys (Futurist), Brian Kally (Director: Arrow Logistics), Jonathan Jansen (Vice-Chancellor and Rector: UFS), Ricardo Peach (Director: Vrystaat Arts Festival, Pamela Nomvete (Former actor and writer), Gil Oved (Founder: Creative Counsel), Pepe Marais (CEO: Joe Public), Angelo Mockie (Senior Officer: Student Affairs and musician), Philippa Tumubweinee (Senior Lecturer in Architecture: UFS), and Melody Mentz (Psychology Senior Professor: UFS).

 

The reason behind the #AskWhy theme

 

"Why is a small word but it’s a quick, broad, sharp and abrupt one,” explains Leeuw. “It is the chosen word of the non-conformist, the defiant, and the visionary. It is a confrontational word. It challenges what is thought to be impossible.”

 

The ability to interrogate reality is what society and economies are built on. The absence of the fear to question encourages the capacity to progress.

 

Motivating young people to follow their dreams is the reason why the TEDxUFS team is persistent in their endeavours. Molete believes that, in order to change anything, people need to ask why.

 

Background of the innovation powerhouse called TED(x)

 

TED is a renowned international non-profit organisation dedicated to disseminating “ideas worth spreading” in the form compelling talks lasting up to 18 minutes.

 

In 1984, it was introduced as a conference exploring Technology, Entertainment, and Design. Three decades later, TED covers a wide variety of topics of global significance, reflecting the contemporary era in more than 100 languages.

 

TEDx events are under the TED umbrella. These events are organised independently, and create a platform for deliberating on local matters. The programme assists communities, organisations, and individuals to stimulate critical dialogue.

 

On 25 July 2014, the UFS hosted its inaugural TEDxUFS conference at the Odeion theatre on the Bloemfontein Campus, where eleven speakers addressed an audience of 150 people on interdisciplinary topics ranging from economics to entrepreneurship, technology, art, design, and theology.

 

This year, 200 seats will be available for innovative revolutionary individuals in search of inspiration.

 

Tickets are available at 0619284253 / 079 381 4126. Prices: R80 (Student/scholars) and R350 (Public/staff)

 

LINKS:

Lerothodi Molete- http://whoswho.co.za/lerothodi-molete-742022

Bonginkosi Leeuw- https://www.ted.com/tedx/events/10499

TEDxUFS- http://kovsielife.ufs.ac.za/templates/archive.aspx?news=276

Mmusi Maimane- http://whoswho.co.za/mmusi-maimane-44612

Garett Cliff- http://www.garethcliff.com/

Pieter Geldenhuys- http://pietergeldenhuys.com/

Brian Kally- https://za.linkedin.com/pub/brian-kally/4b/888/959

Jonathan Jansen- http://www.ufs.ac.za/adhoc-pages/rectorate/prof-(jd)-jonathan-jansen

Ricardo Peach- http://ricardopeach.com/

Pamela Nomvete- http://whoswho.co.za/pamela-nomvete-4789

Gil Ovid- https://za.linkedin.com/pub/gil-oved/3/910/892

Pepe Marais- http://joepublic.co.za/people

Angelo Mockie- https://za.linkedin.com/pub/angelo-mockie/27/56/302

PhilippaTumubweinee- http://natagri.ufs.ac.za/templates/staffmember.aspx?DCode=101&pid=zyNJm7KI%2b1k%3d

Melody Mentz- https://za.linkedin.com/in/melodymentz

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