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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

Teacher professionalism and status under Commonwealth radar
2010-03-26

 
From the left are: Ms Simone De Cormarmond, Chairperson: Commonwealth Foundation; Prof. Jonathan Jansen, Rector and Vice-Chancellor, University of the Free State (UFS); Mr Samuel Isaacs, CEO: SAQA; and Dr Carol Anne Spreen, Lecturer at the University of Maryland, USA).
Photo: Ian van Straaten


International delegates attending the 5th Annual Commonwealth Teacher Research Symposium held at the University of the Free State (UFS) in Bloemfontein this week unanimously agreed that more research still had to be done on issues of recognition, registration and standards affecting teachers and teaching across Commonwealth countries.

This two-day gathering of researchers, officials and representatives of regional international organisations and higher education institutions agreed that issues of teacher migration, the professionalism of teachers, teacher preparation and the use of teaching standards, as well as the comparability and recognition of teacher qualifications should be further researched.

The delegates agreed on the following based on the research and data that were presented and shared with all the participants:

Teacher migration is recognised as an increasing global phenomenon that requires ongoing research in the Commonwealth.
Recognising that inequalities and differences within and across Commonwealth countries exist, and considering that fair and ethical treatment in the international recruitment of teachers is an important cornerstone of the Commonwealth Teacher Recruitment Protocol.

Teacher training, the recognition of teacher qualifications, the professional registration of teachers and the development of professional teacher standards should be actively encouraged through ongoing pan-Commonwealth research.

An increased acknowledgement of the role of the professionalisation of teachers through an improved understanding of teacher qualifications and standards.
There should be a specific research focus on teacher preparation and the use of teaching standards.

An increased comparability and recognition of teacher qualifications across Commonwealth countries should be actively encouraged.
Advocacy of teachers’ rights, effective protection of the vulnerable teacher, and appropriate strategies should be promoted to uplift the status of teachers and teaching as a profession.

The Commonwealth Teacher Recruitment Protocol, amongst other things, aims to balance the rights of teachers to migrate internationally against the need to protect the integrity of national education systems, and to prevent the exploitation of the scarce human resources of poor countries.

Delivering his keynote address at the symposium, the Rector and Vice-Chancellor of the UFS, Prof. Jonathan Jansen, decried the quality of professional qualifications in South Africa.

“We have become very good at manufacturing outcomes. We actually have become very good at giving an impression of having achieved particular outcomes without having achieved them at all,” he said.
“So what does it mean to talk about outcomes in an unequal country with unequal resources? What does it mean to talk about qualifications when we do not trust the outcomes?”

He suggested that the teaching profession should be subjected to a peer review mechanism and that the practice of setting minimum standards should be dealt away with because it results in minimum outcomes.

Dr Carol Anne Spreen, lecturer at the University of Maryland in the USA, proposed that countries should improve the quality of their own teachers instead of importing teachers from other countries.

The research symposium was organised by the Commonwealth Secretariat and hosted by the South African Qualifications Authority (SAQA) and the UFS.

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

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