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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

Prof Tim Murithi calls for Africa to design new global order
2016-06-02

Description: Prof Tim Murithi calls for Africa to design new global order Tags: Prof Tim Murithi doen ’n oproep op Afrika om ’n nuwe wêreldorde te skep

From left: Prof Heidi Hudson, Head of Centre for Africa
Studies (CAS); Prof Tim Murithi, Extraordinary Professor
at CAS; Prof Lucius Botes, Dean of the Faculty of
the Humanities; and Prof Prakash Naidoo, Principal of
Qwaqwa Campus.
Photo: Stephen Collet

“What do Africans have to say about the remaking of the global order?” was the opening question of Prof Tim Murithi’s lecture which was hosted by the Centre for Africa Studies (CAS) of the University of the Free State (UFS) to celebrate Africa Day on 25 May 2016.

The annual Africa Day Memorial Lecture, entitled: Africa and the Remaking of the Global Order, doubled as Prof Murithi’s inaugural lecture. He is CAS’s newly-appointed Extraordinary Professor, as well as the Head of the Justice and Reconciliation in Africa Programme at the Institute for Justice and Reconciliation in Cape Town. He made a compelling argument for the need for Africa to exert an active influence on international narratives of peace, governance, justice, and reconciliation.

“If we are waiting for American leadership to get us out of the quagmire of a situation we are in, we will be waiting for a long time,” said Prof Murithi.

The Head of the Centre, Prof Heidi Hudson, concurred with Prof Murithi’s suggestion of devising African solutions for African problems. She quoted Audre Lorde’s well-known assertion that “The master’s tools will never dismantle the master’s house.”

Remembering 1963
Over five decades ago, on 25 May 1963, the Organisation of African Unity was formed, and was renamed the African Union in 2002. Africa Day marks this pivotal point in the continent’s history. On this day, we reflect on the continent’s journey into democracy, peace, stability and socio-economic development. It is also an opportunity to celebrate African identity and heritage.

Continent-building dialogues
The UFS Sasol Library celebrated Africa Day with a book launch. Facets of Power. Politics, Profits and People in the Making of Zimbabwe's Blood Diamonds by Tinashe Nyamunda is a reflection of some of the challenges that Zimbabwe continues to face. It details the disadvantaged position which the country finds itself in due to greed, maladministration, and corruption, despite possessing large deposits of minerals.

In celebration of Africa Month, CAS has held a series of lectures by esteemed scholars from across the globe.  Earlier in the month, Prof Henning Melber presented lectures on Namibia’s independence and the African middle class. Kevin Bloom and Richard Poplak unpacked the issues surrounding Africa’s continental shift, while Prof Joleen Steyn Kotze focused on the possible fall of the African National Congress.

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