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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

African Student Affairs Conference a huge success
2011-05-24

 
Mr Rudi Buys, UFS Dean of Student Affairs, Mr. Folabi Obembe, Managing Director of Worldview International, Ms Birgit Schreiber, Director of the Centre for Student support services at the University of the Western Cape, Dr. Augustinah Duyilemi, Dean of Student Affairs at the Adekunleh Ajasin University in Nigeria, Dr. Christina Lunceford, assistant Director for the Centre for Research on Educational Access and Leadership at California State University in America, and Prof. Cecil Bodibe, student affairs veteran and consultant.
Photo: Earl Coetzee

The African Student Affairs Conference (ASAC), which took place on our Main Campus last week, was a major success, with two days of lectures and discussions and two pleasant social gatherings, where delegates had the opportunity to get to know each other.

The conference, hosted on African soil for the first time, and co-hosted by the University of the Western Cape (UWC), started on Wednesday 18 May 2011 with an informal welcoming session. Delegates got to meet each other and Mr Rudi Buys, UFS Dean of Student Affairs, explained the meaning of South African words like "kuier" and "lekker'.

The official start of events took place on Thursday 19 May 2011, in the Reitz Hall in our Centenary Complex. The conference was attended by delegates from universities across the continent and aimed to place the focus on issues relating to student affairs in an African context.

Delegates shared and exchanged strategies, ideas and resources, and discussed issues related to the work of student affairs professionals. The conference hoped to promote an exchange of best practice and assist attendees in identifying successful programmes.

Among the topics discussed on the first day, were “Constructing Post-Conflict Democracy on campus: a case study of transformation of student governance and political engagement as post-conflict intervention”, by Mr. Buys, and a discussion on ways in which social and online media can be used to ease the challenges of student interaction, development and support, by Ms Birgit Schreiber, Director of the Centre for Student Support Services at UWC.

A panel discussion, led by Mr Buys and several members of our Interim Student Council (ISC), discussed the specific challenges faced at the UFS.  The importance of buy-in from role-players in decisions taken by University management in order to ensure their success, was discussed, using the UFS and our recent changes as an example.

The successful integration of residences on campus inevitably came under the spotlight and the recently resolved Reitz-saga was named as a catalyst in getting students less apathetic and more involved in attempts at creating racial and social harmony.

Dr Christina Lunceford, Assistant-Director of the Centre for Research on Educational Access and Leadership at California State University, presented a paper entitled A National Approach to Building Capacity in Student Affairs in South African Higher Education.

She commented on the fact that there is little or no philosophical framework or explicit theory that informs practice of student services in South Africa.

According to Dr Lunceford, student development should be a key concern for every department or unit within student services and emphasized the need for a centralized student development unit at each university.
She also touched on the need for institutions to implement support from international student affairs professional associations, professional development for student affairs practitioners, the utilization of technology to support professionals in the field, and working with international partners to explore future opportunities, as ways in which student affairs can be used to drive performance and change at universities.

The conference continued in the Scaena theatre on Friday 20 May 2011, with presentations by Dr Augustinah Duyileme, Dean of Student Affairs at Adekunle Ajasin University in Nigeria, and Prof. Bobby Mandew, Executive Director of Student Affairs at the University of Johannesburg (UJ).

Dr Duyileme presented a paper on the challenges faced by Nigerian universities with regard to student conflict and protests, which often turn violent, and how such violence can be curbed through proper planning and management.

Prof. Mandew presented a very well-received presentation on UJ’s successful off-campus housing initiative, which involves home-owners and business owners in the areas surrounding their campuses.

Their approach demonstrated how proper planning can prevent problems associated with over-population in private homes and conflict with neighbours of the university, usually related to an influx of students into residential neighbourhoods.

This problem is faced by many universities, as more and more students flock to universities on the continent and campus residents cannot accommodate them.

The conference came to a close on Friday, with most delegates agreeing that the exchange of knowledge which took place was extremely valuable.

Ms Deborah Lahlan, of Nigeria, said: “This is an important conference for Africa and it should become a regular event.”
 

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