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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 to honour past and present Cabinet ministers
2010-04-19

The University of the Free State (UFS) is going to confer honorary doctoral degrees on former Minister of Arts, Culture, Science and Technology, Dr Ben Ngubane, and the current Minister of Finance, Mr Pravin Gordhan, during the university’s autumn graduation ceremony next month.

They will receive their honorary doctorates on 18 and 19 May respectively.

“It is an honour for the UFS to confer these honorary doctorates on people like these who have made, and continue to make outstanding contributions towards the wellbeing of this beautiful country. Being associated with people of this stature signifies the direction that the UFS is taking in our quest to be a great university, one of the best in the world,” said Prof. Jonathan Jansen, the Rector and Vice-Chancellor of the UFS.

Dr Ngubane will be honoured for his immense contribution towards positioning South Africa as a major and an influential player in the development of arts, culture, science and technology internationally.

He was the first Minister of Arts, Culture, Science and Technology in the new, democratic South Africa appointed by the former President, Nelson Mandela, in 1994. He was re-appointed to lead this ministry again by former President Thabo Mbeki in 1999.

As Premier of KwaZulu-Natal from 1996 to 1999, Dr Ngubane is credited for his role in bringing about peace and reducing the political violence that ravaged the province at that time.

In 2004 he was appointed as Ambassador to Japan where he initiated, among other projects, the South Africa-Japan University Forum (SAJU).
He has been honoured for outstanding contributions to higher education and community development and holds Honorary Doctorates from the universities of Natal, Zululand, the Medical University of South Africa (Medunsa) and the Tshwane University of Technology.

He is currently the Chairperson of the SABC Board.

Minister Gordhan, on the other hand, formed an integral part of the constitutional transition of South Africa between 1991 and 1994. He chaired the Convention for a Democratic South Africa (CODESA) Management Committee – the midwife and negotiating forum for a free South Africa. He was also co-chair of the Transitional Executive Council, which was a governance structure tasked with ensuring South Africa’s transition process prior to the historic 1994 elections.

In 1994, with the dawn of a new democracy in South Africa, Mr Gordhan became a Member of Parliament and was elected as Chairperson of the Parliamentary Constitutional Committee, which oversaw the implementation of the new constitutional order. At the same time he played a leading role in drafting the present constitution of the democratic South Africa. He also led the process of formulating a new policy framework for local government transformation.

Mr Gordhan was appointed as Deputy Commissioner at the South African Revenue Service (SARS) in March 1998 after being deployed from Parliament as part of the government’s drive to transform the public service. The following year he was appointed as Commissioner for SARS with the important task, amongst others, to transform South Africa’s Customs and Revenue administration – a strategic governmental institution.

He has represented South Africa in many international undertakings, including several peacekeeping missions, as Chairperson of the Customs Workshop for the Second Global Forum on Fighting Corruption and Safe-Guarding Integrity (2001), and is often called upon to make presentations at tax seminars and customs conferences.

In 2000 he was appointed Chairperson of the Council of World Customs Organisation (WCO), based in Brussels, a position to which he was re-elected twice, thus serving from 2000 to 2006.

Media Release
Issued by: Mangaliso Radebe
Assistant Director: Media Liaison
Tel: 051 401 2828
Cell: 078 460 3320
E-mail: radebemt@ufs.ac.za  
19 April 2010
 

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