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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

Government supports the UFS's transformation push
2009-09-04

The Minister of Higher Education and Training, Dr Blade Nzimande (pictured), has lauded the University of the Free State (UFS) for the progress it has made in increasing access for black students.

However, the minister also acknowledged that the UFS has failed in some respects to make important changes.

“The continued racial segregation of the hostels is something that is unacceptable 15 years after the introduction of a democratic order and has no doubt contributed to the kinds of attitudes that led to the notorious incident at the Reitz Hostel last year,” he said.

Dr Nzimande was delivering the JN Boshoff Commemorative Lecture on the Main Campus in Bloemfontein last night.

He said the Rector and Vice-Chancellor of the UFS, Prof Jonathan Jansen, has assured him that he will speed up this issue of residence integration and that he was confident he will do so successfully with the support of the overwhelming majority of the university community.

“He has my support in his new role and he will succeed in taking the university forward decisively along the path towards greater academic excellence and to serving its students and staff, the Free State province and South Africa as a whole, including its poorest and most disadvantaged citizens,” he said.

He said the UFS is an important national asset and “not an asset for some to the exclusion of others”.

“We will play our part as the Department of Higher Education and Training to support you in pursuing transformation, but we won’t keep quiet when we see that there are things that are developing that are actually undermining the realization of the UFS as a national asset,” he said.

Despite the fact that all our universities, he said, have policies in place to combat racism and discrimination, the Soudien Report shows that there is a disconnection between policy and actual discriminatory practice at universities.

“This is a serious problem because this disjuncture is not only because of the actions of maverick individuals on the ground, but includes the universities’ leadership, including even University Councils which are guilty of making policy in order to comply with legislation but expect that policy to be ignored in practice,” he said.

The Soudien Report is a Report of the Ministerial Committee on Transformation and Social Cohesion and the Elimination of Discrimination in Public Higher Education Institutions commissioned by the Department of Education last year.

Dr Nzimande also raised the fact that universities have neglected the Further Education and Training (FET) college sector in terms of research and teaching.

“There is not enough research by the universities on the FET college sector and yet this is the sector that we are prioritizing to absorb many of our young people who can’t make it to universities,” he said.

“We want to try and fight against this notion that in order to proceed in life university is the only place. We want to turn these FET colleges into colleges of choice and universities must help us, not only to research them but also to train FET colleges lecturers.”

He also announced that he will be calling a meeting of all the chairpersons of the Institutional Forums of the universities later this month as he feels that the role and status of these forums have been “eroded”.

Media Release
Issued by: Mangaliso Radebe
Assistant Director: Media Liaison
Tel: 051 401 2828
Cell: 078 460 3320
E-mail: radebemt.stg@ufs.ac.za  
04 September 2009
 

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