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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

Physics Department sheds light on mystery of dark matter through films and radio programme
2017-06-23

Description: Dark Matter Tags: Dark Matter

The screening of The Dark Matter Mystery and Dark
at the Naval Hill Planetarium was followed by a discussion
recorded for the radio programme Sterre en Planete
on RSG. From left are Mariette Erwee, Senior Officer at
the School of Mathematics, Natural Sciences and
Technology Education of the UFS, Prof Matie Hoffman,
Associate Professor at the Physics Department of the UFS,
Hennie Maas, from RSG, and Sakkie van der Westhuizen,
PhD student in astrophysics.
Photo: Mart-Mari Duvenhage

The Physics Department at the University of the Free State (UFS) not only recently educated the local community about the mystery of dark matter, but shared its knowledge with a much wider audience.

The first screening of two planetarium full-dome films, The Dark Matter Mystery and Dark, at the Naval Hill Planetarium were concluded with a recording for the radio programme Sterre en Planete. During the discussion, led by Hennie Maas from RSG radio station, the audience asked questions that were answered by Prof Matie Hoffman, Associate Professor at the department, Sakkie van der Westhuizen, a PhD student in astrophysics, and Mariette Erwee from the School of Mathematics, Natural Sciences and Technology Education. The radio show was broadcast on 18 June at 19:30 on RSG.

Shows screened at special event
According to Prof Hoffman the planetarium hosts a movie premiere whenever pre-rendered shows are screened for the first time. The films shown on 10 June 2017 introduced viewers to the quest for dark matter. “Dark Matter makes up a huge part of the Universe, but it is a great mystery. We know very little about it. We cannot see it, and it is an area of enormous interest to scientists,” Prof Hoffman said.

Films sourced from European Southern Observatory
The event was attended by various stakeholders such as loyal planetarium patrons, UFS colleagues, and those interested in astronomy. The films were sourced from the European Southern Observatory, an organisation that makes planetarium content available online.

The Dark Matter Mystery took the audience on contemporary astrophysics’ biggest quest. They saw why astronomers know dark matter exists. Dark, directed by Peter Morse, is an adventure that goes to the very edges of contemporary cosmology and data visualisation, telling a complex scientific story with a touch of humanity.

The films will be screened at the Naval Hill Planetarium from time to time and those interested can visit Computicket for more info.

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