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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

UFS celebrates Madiba’s legacy with coin-laying ceremony on 18 July 2013
2013-07-15

 

Photo: Johann Roux
08 July 2013

The University of the Free State (UFS) will once again join South Africans as well as the broader international community on Thursday 18 July 2013 in celebration of the enduring legacy of beloved former statesman, Nelson Mandela.

The UFS aims to stay true to the spirit of giving and selflessness epitomised by Mandela Day, focusing on the university community as well as the city of Bloemfontein.

This year’s event will strive to eclipse the success achieved during the 2012 event which featured Archbishop Emeritus Desmond Tutu as special guest.

The festivities on 18 July 2013 will kick off with university volunteers cleaning various areas of Bloemfontein. Departing from the Bloemfontein Campus at 09:00, the volunteers will clean areas in Heidedal and Mangaung with the help of the Mangaung Metropolitan Municipality.

In Heidedal, the volunteers will clean the crèche on the corner of Parish and Lackay roads as well as the old clinic on the corner of Parish and De Vries. In Mangaung, the volunteers will tackle the bustling Free Square on the Dewetsdorp road.

The larger celebration will take place on the Red Square of the Bloemfontein Campus at 12:00. Long-time Madiba confidant, Zelda la Grange, will deliver a message, followed by a R5 coin-laying ceremony.

La Grange will be joined by the motorcycle riders affiliated to the Bikers for Nelson Mandela Day, OFM presenter Johrné van Huysteen who will conduct proceedings, UFS Vice-Chancellor and Rector Prof Jonathan Jansen as well as UFS students, staff, other dignitaries and special guests.

The programme also includes a lucky draw with winners standing the chance to win restored bicycles. Tickets can be purchased through Annelize Visagie at 051 401 3258 or at visagiea@ufs.ac.za. The winners will be announced during the ceremony on the Red Square.

All proceeds of the coin-laying ceremony and lucky draw will be contributed towards the university’s No Student Hungry (NSH) Programme.

The NSH Programme was established in 2011 to help ensure needy students are supplied with a food bursary which provides them with the necessary nourishment to excel in their academic studies. The initiative has since become a university-wide endeavour and currently serves more than 100 students daily on the Bloemfontein and Qwaqwa Campuses.

Rag Community Service will also cater for the specific needs which the harsh Free State winter causes – especially to the poor. Close to 500 blankets will be donated on Mandela Day to five different charities, including Mosamaria Aids Ministry, Choc House and Freshly Young Minds.

For further information, please contact Marissa van Jaarsveld on 051 401 3834 or at nostudenthungry@ufs.ac.za.

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