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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

Call for campus review and participation into renaming and renewal of statues, signs, and symbols on UFS campuses
2016-08-25

 

The leadership of the University of the Free State (UFS) is issuing a Call for the renaming and renewal of statues, signs, and symbols on the three campuses to staff, students, and alumni.

In line with the founding statement and guidelines of the Naming Committee of Council, The Call will seek to retain the best representations of the history and identity of the UFS over more than a century, while committing to the transformation imperatives of our new democracy so that the totality of statues, signs, and symbols give credence to both the past and the future, all in line with the values of the Constitution of the Republic of South Africa.

Submissions should be made to the
SSSC between 21 July 2016 and 31 August 2016.
Proposals can be delivered to the
office of the Director: Communication and
Brand Management at Room 49,
Main Building, Bloemfontein Campus, or
via email to sssc@ufs.ac.za.

The ‘Guiding Principles’ of the Naming Committee, approved by Council on 8 March 2013, are transformation, reconciliation, excellence, distinctiveness, leadership, comprehensiveness, balance and sensitivity. The Policy of the UFS on Naming and Renaming is available here: http://bit.ly/2aeTLUz; and the Remit of the Naming Committee of the UFS is available here: http://bit.ly/29NXESC.

The Call will give special attention to creative submissions from staff, students, and alumni, such as signs and symbols that reflect our entangled past and place rival memories in critical conversation. Whatever is proposed, our commitment to the Academic Project and the Human Project remain foundations on which inspirational proposals could be based. In the end, a campus that is richly diverse, inclusive, and just in its symbolic infrastructure, would give visible meaning to the university’s commitment to social justice and reconciliation.

All submissions should be made to the Statues, Signs, and Symbols Committee (SSSC) between 21 July 2016 and 31 August 2016. Proposals could be delivered in hard copy to the office of the Director: Communication and Brand Management at Room 49, Main Building, Bloemfontein Campus or via email to sssc@ufs.ac.za.

Proposals will be reviewed by the SSSC, which is a subcommittee of the Naming Committee.

Final proposals will be submitted to Council for consideration at its final meeting of the 2016 academic year. In other words, new statues, symbols and signs – those approved by Council – will be implemented from January 2017.

Submissions could include, but are not limited to, the following: the renaming of streets and buildings; the proposal of new statues and other symbols on campus; the renewal of artwork collections; the reconfiguration of existing statues and symbols; the introduction of memorial gardens; the instatement of new galleries, sculptures, and literary collections; the establishment of prominent academic chairs or annual academic lectures in the name of illustrious figures, etc. Particular attention should be given to new buildings in the process of being built, such as residences.

Finally, it is important that the views and recommendations of all staff, students, and alumni be considered in submissions and that every campus citizen, past and present, has a sense of being able to participate fully and freely in the process.

Released by: Lacea Loader (Director: Communication and Brand Management)
Tel: +27 51 401 3422/2707 or +27 83 645 2454
Email: news@ufs.ac.za | loaderl@ufs.ac.za
Fax: +27 51 444 6393

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