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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

Migration is a developmental issue - experts
2010-06-01

Pictured from the left, front, are: D. Juma, Mr Williams and Prof. Hussein Solomon (University of Pretoria); back: Prof. Bekker, Prof. Lucius Botes (Dean: Faculty of the Humanities, UFS) and Dr Wa Kabwe-Segatti.
Photo: Stephen Collett


“Migration offers more opportunities for economic growth than constraints. It is an integral part of the processes of globalisation and regional integration.”

This was a view shared by one of the speakers, Dr Monica Juma from the Africa Institute of South Africa, during a panel discussion hosted by the Centre for Africa Studies (CAS) at the University of the Free State (UFS) last week as part of the celebrations of Africa Day on 25 May 2010.

The discussion was premised on the theme, Migration and Africa: From Analysis to Action.

Dr Juma said migrants could be assets for host countries or cities because of their resourcefulness. She said they brought along essential skills that could contribute immensely to the economic development of their host countries or cities.

“Governments are beginning to see migration as a tool for development and working together in developing immigration policies,” concurred another speaker, Mr Vincent Williams from the Institute for Democracy in South Africa (IDASA).

He said, if managed properly, migration could yield positive results. He said effective management of migration should start at local and provincial levels.
And for this to happen, he said, the current immigration laws should be amended as he felt they were no longer relevant, because they were based on what countries wanted to achieve in the past.

“Reform national immigration legislation to encourage permanent settlement and improve service delivery mechanisms and bureaucracy to match population movements,” Dr Aurelia Kazadi Wa Kabwe-Segatti, from the Forced Migration Studies Programme at the University of the Witwatersrand recommended.

However, Mr Williams pointed out that policy convergence was a difficult thing to achieve as migration was a politically sensitive issue. He said decisions that countries made on migration could have a negative or a positive bearing on their relations with one another.

Dr Juma also raised the issue of unskilled migrants which, she said, could be a burden to governments. This was reflected in the current South African situation where foreigners offered cheap labour and thus rendered South Africans who demanded higher salaries unemployable. This was a contributory factor to the xenophobic attacks of 2008. What was essentially a labour problem then manifested itself as a migration problem.

Prof. Simon Bekker from the University of Stellenbosch said South Africa was still losing a significant number of skilled professionals to Europe and North America due to an assumption that spatial mobility led to social or economic mobility.

He also suggested that the government should not restrict internal migration but should address the problem of migration across the borders into South Africa.

Senior Professor at the CAS, Prof. Kwandiwe Kondlo, said while the discussion covered a broad scope, there were some gaps that still needed to be filled in order for an all-inclusive view to prevail. One such gap, he said, was to also accord indigenous traditional institutions of governance space in such deliberations and not base discussions on this issue only on the Western way of thinking.

Africa Day is the day on which Africa observes the creation of the Organisation of African Unity (OAU) on 25 May 1963, to promote the unity and solidarity of African states and act as a collective voice for the African continent; to secure Africa’s long-term economic and political future; and to rid the continent of all remaining forms of colonialism. The OAU was formally replaced by the African Union in July 2002.

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

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