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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

2015/2016 SRC candidates announced
2015-08-19


Ledimo Nthejane, Independent Electoral Commission Provincial Manager, announcing the contenders for SRC elections at the Bloemfontein Campus.
Photo: Johan Roux

Congratulations to the successful 2015/2016 Student Representative Council (SRC) nominees. We wish you all the best with your campaigning.

The Electoral Commission of South Africa (IEC) has been appointed by the UFS to take responsibility for the operational aspects of the upcoming SRC elections on the Bloemfontein campus.  Their involvement spans over the period from the nomination process up to the announcement of the election results on 3 September 2015.

Bloemfontein Campus:

  • Edward de Wet (President)
  • Lindokuhle Ntuli (President)
  • Mpho Khati (Vice-President)
  • Nigel Marchall Masalla (Vice-President)
  • Nicola King (First-generation students)
  • Brand Louw (First-generation students)
  • Dineo Khotso Mashile (Transformation)
  • Katleho Mmolayeng Letube (Transformation)
  • Jeanne-Mari McDonald (Legal and Constitutional Affairs)
  • Lesley-Anne Terblanche (Legal and Constitutional Affairs)
  • Luke Harrold Small (Legal and Constitutional Affairs)
  • Nomathamsanqa Nomvula Kraai (Legal and Constitutional Affairs)
  • Victor Sejane (Student Accessibility)
  • Sam-Maree Rooi (Student Accessibility)
  • Rememberance Rohula Kgabu (Student Accessibility)
  • Delia Moumakwe (Culture)
  • Mohau Moses Lesebo (Culture)
  • Kabelo Elijah Noosi (Sport)
  • Neo Gift Thebe (Sport)
  • Peo Morwesi Segano (Media and Marketing)
  • Gali Moticoe (Media and Marketing)
  • Mafelleng Itumeleng Matla (Student Development and Environment)
  • Karabo Pheko (Student Development and Environment)
  • Shaun Grobler (Treasurer)
  • Cornel Vermaak (Treasurer)
  • Katleho Masheane (Treasurer)
  • Thulani Babeli (Treasurer)
  • Nothando Hlophe (Secretary)
  • Tsietso Mafaso (Secretary)
  • Mihlali Matanzima (Secretary)

Qwaqwa Campus:

  • Tseko Masoeu (President)
  • Ntokozo Mbele (President)
  • Paseka Sikhosane (President)
  • Ntandoyenkosi Mndebele (President)
  • Zethu Mhlongo (Deputy President)
  • Limpho Mape (Deputy President)
  • Mpho Pooe (Deputy President)
  • Langelihle Mzobe (Deputy President)
  • Bannetse Mokhatla (Secretary General)
  • Londiwe Shezi (Secretary General)
  • Nondumiso Langa (Secretary General)
  • Palesa Selepe (Treasurer General)
  • Sabelo Vilakazi (Treasurer General)
  • Sinenhlanhla Mfeka (Treasurer General)
  • Solomuzi Khathi (Treasurer General)
  • Busisiwe Nkosi (Politics and Transformation)
  • Banele Mndwaweni (Politics and Transformation)
  • Nthabiseng Mokoena (Politics and Transformation)
  • Sibusiso Nyambose (Media and Publicity)
  • Nonkululeko Shabalala (Media and Publicity)
  • Khulani Mhlongo (Media and Publicity)
  • Bongiwe Buthelezi (Media and Publicity)
  • Nhlanhla Shabalala (Student Development and Environmental Affairs)
  • Thulane Dubazane (Student Development and Environmental Affairs)
  • Lindokuhle Ngubane (Student Development & Environmental Affairs)

Nominations for the Secretary and Treasurer portfolios are still open until 12:00 noon on Friday 21 August 2015.

Important dates to note:

18 August 2015 - Bloemfontein and Qwaqwa Campus campaigning commences

27 August 2015 - Qwaqwa campaigning ends

30 August 2015 - Bloemfontein campaigning ends

28 August 2015 - Qwaqwa Election Day

31 August 2015 - Bloemfontein Election Day

1 September 2015 - Qwaqwa SR handover and establishment sitting

4 September 2015 - Bloemfontein SRC handover and establishment sitting

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