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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 establishes a Postgraduate office
2007-07-18

The University of the Free State (UFS) will establish a postgraduate office that will serve as a one-stop service for the co-ordination of academic support services for postgraduate students.

According to the Director: Research Development at the UFS, Prof Frans Swanepoel, the primary purpose of the Postgraduate Office is to provide co-ordination and support services for postgraduate students and postdoctoral fellows, as well as academic staff across the University.

“Guided by values such as intellectual inquiry, innovation, collegiality, integrity and efficiency, the Postgraduate Office will seek to foster a challenging, inclusive and supportive environment for postgraduate teaching, learning, research and scholarship; and will strive to engage students in the vibrant life of a research university”, Prof Swanepoel said.

All sectors of the University, namely students, faculties and staff, stand to benefit from the establishment of this office. Amongst other benefits for these sectors, postgraduate students and postdoctoral research fellows will have their interests promoted in synergy with faculty and departmental facilities. On the other hand, the office will provide a critical resource to the faculties in the form of a single database of postgraduate students, postgraduate topics, supervisors and funding opportunities. Furthermore, it will serve as a useful resource and base for training and information for younger and less experienced staff members.

The establishment of this office will be undertaken in two phases. The first phase will focus on the most critical areas that will make an immediate impact and the second phase on those areas that are not as urgent.

Areas that will be prioritised include the appointment of a manager and co-ordination of stakeholders, the provision of information and communication, useful resources for the UFS, policy administration and monitoring, postgraduate supervisors’ facilitation, recruitment activities, advice and referral, and postgraduate scholarship and bursary management.

The less urgent components of the office will be the development and implementation of academic and professional support programmes, the formation of a research information commons to create an integrated learning environment for postgraduate students, and the development of a postgraduate association or a postgraduate students’ liaison committee to provide a recognised channel of communication between postgraduate students and the University authorities.

The Postgraduate Office will form a vital component of the Directorate Research Development (DRD) at the UFS because of its experience and a noteworthy track record with regard to a facilitative and co-ordinating role that would be essential for the office.

“Establishing the Postgraduate Office as part of the Directorate would give the Centre the necessary links to the research-related issues that are important to most of the postgraduate students at the UFS. Of essential importance will be the linkages with the full spectrum of Strategic Clusters”, Prof Swanepoel explained.

“An important component of the Postgraduate Office will be related to international students and international opportunities for UFS postgraduate students. As the Office for Internationalisation has similarly been placed within the Directorate, the work of the Postgraduate Office will be facilitated by similar placement within the same Directorate”, he concluded.

Media release
Issued by: Mangaliso Radebe
Assistant Director: Media Liaison
Tel: 051 401 2828
Cell: 078 460 3320
E-mail: radebemt.stg@mail.ufs.ac.za  
18 July 2007
 

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