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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

Address by the first Inaugural President of the Central SRC
2005-08-03


 

The UFS Central SRC

Address by the first Inaugural President of the Central SRC of the University of the Free State, Mr Tello Motloung on Wednesday 3 August 2003

The Chairperson of the UFS Council, Judge Faan Hancke,
The Vice-chancellor and Rector of the UFS, Prof Frederick Fourie
The Vice-Rector Student Affairs of the UFS, Dr Ezekiel Moraka
The Presidents of the main campus SRC and the Vista campus SRC
Colleagues in the Central SRC, campus SRCs, students and fellow South Africans

Please receive my heartfelt revolutionary greetings

Vice-chancellor and rector what I bring here with me assisted by facts, is just the work of my imagination. Like a love letter addressed to a sweetheart miles away, even though you do not know how she feels, what she wants to hear, and do not even know what she looks like.

I value speech as just an honest intimation, that’s why I got into a habit of establishing a dialogue with people, looking at each other’s face, and persuading one another of what we are saying.

Vice-chancellor, today marks an important milestone in the history of the existence of the UFS. Today reflects the confidence and trust that students of the UFS have placed in us. They are confident that the Central SRC has both the will and the capacity to take our university forward as we confront the challenge of transformation.

Students are confident that they are correct to trust the Central SRC as the principal agent of change in our university that is genuinely committed to the objective of building a non-racial, non-sexist and democratic university. We need to frankly ask ourselves, as CSRC members, whether are we up to all these challenges?

All Central SRC members have to understand this fully, internalize it, and ensure that everything we do, does not betray the confidence and trust of students, or disappoint their expectations. I say this knowing that all Central SRC members have committed themselves to serve the students of the UFS, black and white, and no one among us (CSRC) needs any special lectures about this central commitment.

The UFS should be an omnibus, welcoming everybody on board. But we should be a bus with a clear direction. We will certainly lose our way if we, as an institution, don’t have a clear road map spelling out where we are heading to.

There should be clear guidelines on the role of students in the transformation process. Students should also be viewed as role players in transformation along with the University management, and not just opposing forces. There is no right time, other than this one, to move away from the politics of opposition to politics of transformation.

However, we need the support of management to do so. The University should value the role and contribution of student leaders, hear our legitimate claims and consider them as part of political and policy decision making.
     
Vice-chancellor and Rector, it remains our task to ensure that the UFS is transformed into an institution that is seen to be playing a vigilant role in developing students academically, intellectually, socially, culturally, politically and otherwise. The process of transformation is not ending tonight, it is just beginning tonight.

Judge Hancke, Prof Fourie, Dr Moraka, fellow students and fellow South Africans, I lead students at this university with a sense of pride and duty, and I know very well that I lead men and women, students who are all determined that we reach our destination safely and on time.

A navy divided within its ranks will be destroyed and vanquished by the enemy, but the navy united in purpose and action, loyalty and commitment will not sink but sail on to victory.

It is befitting to mention that every drop of my blood is telling me that the UFS is my home. I firstly became a student here, I became the SRC treasurer in my first year here, I became the deputy president here, and I became the first president of the Central SRC of the UFS.

Therefore you should never doubt my commitment towards the transformation of this university. To paraphrase what was said by students at another institution, “If there is no UFS in heaven, then I am not going.”

Let me conclude by thanking my ancestors for teaching me that even if I wined and dined with kings and queens, I am not a king myself, so I should not turn my back on people who made me what I am today.

Most importantly, I would like to thank the Almighty God and the grace of our Lord Jesus Christ for giving me time and power to lead this university.

It will be theoretically irresponsible if I ended my speech without indicating that “Only a Kovsie knows the feeling”.

I thank you.

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