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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

The UFS issues a statement regarding the outcome of recent court case
2014-09-15

A significant number of reports appeared in the media the past week regarding this alleged attack, which happened on the Bloemfontein Campus of the UFS on 17 February 2014.

Although the senior leadership of the UFS is always in favour of good and objective journalism, we find it unfortunate that some of the facts are reported in a misleading and/or inaccurate way by some of the local media.

It is important to us that the true facts are stated. Not only for the sake of those involved, but also for our staff, students, alumni and other important stakeholders.

Here are the facts:

1.    The university was not the complainant. The alleged incident was reported to the South African Police Service (SAPS) by the victim, Muzi Gwebu, and the charges were laid by the State.

2.    At no point did the university management in any of its public statements describe this incident as a case of racism; not once. Charges of racism, then and now, must be proven, not assumed to be true simply because someone alleges racism. That is our standard approach, then and now.

3.    Cobus Muller and Charl Blom were suspended by the university, not expelled – pending the results of the court case. Emotions were running high among members of the student body and, on grounds of the evidence available to the university management at the time, as well as concerns for student and campus safety, they were suspended pending the outcome of a court hearing. This is normal procedure. Suspension does not mean you are guilty; it means you have a case to answer, either according to the university's disciplinary procedures or in the courts. For these reasons the university management will not apologise for the suspension.

4.    The university awaited the outcome of the court case before deciding whether disciplinary action should also be taken against Cobus Muller and Charl Blom. In the light of both the South African Human Rights Commission (SAHRC) and the Regional Court rulings, the university management subsequently decided to lift the suspensions of both Muller and Blom from all campuses of the university with immediate effect.

Muzi Gwebu laid serious charges with the SAPS almost immediately after the incident, and the university management believed, on the evidence then available, that the students had a case to answer.
 
5.    As the Director of Public Prosecutions decides on who will be prosecuted and who not, there are no grounds for the university to pay the legal fees of any of the students in this case.
 
Finally:
The University of the Free State will not be fazed by inaccurate and distorted information, rumour and exaggerations. We are still striving to become a truly excellent university, with a focus on the academic, but also the human development of our students.

Issued by: Lacea Loader (Director: Communication and Brand Management)
Tel: +27 (0) 51 401 2584 | +27 (0) 83 645 2454
E-mail: news@ufs.ac.za

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