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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

UFS Department of Physics offers unique learning experience with on-campus radio telescope
2015-12-14

Athanasius Ramaila, an Honours student in the Department of Physics, and Dr Brian van Soelen, a lecturer from the same department, in the laboratory where the radio telescope is housed in the new wing of the Physics Building on the Bloemfontein Campus of the UFS. The telescope will be used to expose graduate students to the basic techniques of radio astronomy.
Photo: Charl Devenish

The university this year added a four-storey wing to the existing Physics Building on the Bloemfontein Campus. The new development, which includes four lecture halls and four laboratories, complements other world-class facilities such as the X-ray photoelectron spectroscope and the scanning electron microscope.

A unique asset that distinguishes the UFS Department of Physics from other similar institutions, is the Boyden Observatory situated approximately 27 km northeast of Bloemfontein. The observatory houses a powerful 1.5 m optical telescope, and several smaller, but well equipped telescopes.

According to Pieter Meintjes, Professor in the Department of Physics, the observatory has acquired a new addition - a 0.5 m optical telescope donated by the South African Astronomical Observatory (SAAO) and the National Research Foundation (NRF) to the UFS Astrophysics Group. This optical telescope is one of two powerful optical telescopes used to introduce students to techniques such as photometry and spectroscopy.

“The telescope at Boyden forms an integral part of the Department of Physic’s student training and research programme. Because the UFS is the only university in South Africa operating such a facility, and one of only a few globally, Astrophysics students at the UFS have the unique privilege of having unrestricted access to these telescopes for their MSc and PhD studies,” says Prof Meintjes. In addition, the department has also built a radio telescope as part of a post-graduate student project. The telescope, housed in the new wing of the Physics Building at the Bloemfontein Campus of the UFS, will be used to expose graduate students to the basic techniques of radio astronomy, especially in light of the fact that the SKA is nascent. Prof Meintjes would like to act proactively by grounding his students in the relevant techniques of radio astronomy. The telescope will be used to introduce students to the manner in which radio flux calibrations are performed in order to determine the energy output of an emitting source.

At undergraduate level, the radio telescope will be used, together with optical telescopes in the Astrophysics laboratory, to place students at a high baseline regarding the level of multi-wavelength astrophysics training received at the UFS.

Third-year and Honours students will also have the opportunity of practical training in a research laboratory with 15 computers. The laboratory is equipped with software used to reduce and analyse multi-wavelength data.

“My goal is for the UFS to become the major centre of multi-wavelength astrophysics in South Africa and a key role player in the international arena. To be able to do this, our training should be world class,” Prof Meintjes said.

Aided by its world-class facilities and research, the Department of Physics is competing with the best in the world. Research-wise, a group from the Department of Physics is intensively involved with the SKA Project (Square Kilometre Array), with 3 000 dishes reaching from Carnavon in the Karoo to Mauritius in the Indian Ocean. According to Prof Meintjes, many detailed studies can be conducted with the SKA system of sources, showing major eruptions and mass effluent from the systems. Athanasius Ramaila, a BSc Honours student in Astrophysics at the UFS, has also received a two-year SKA internship, where he will be engaged in the SKA software engineering programme to help with developing software for the telescope.

The UFS Astrophysics Group is focusing on the multi-wavelength study of high-energy astrophysics sources. “This multi-wavelength approach to astrophysics is in line with the recent announcement by government that multi wavelength astrophysics will be the main focus for astrophysics research in South Africa. It is also a very important focus for research in the international arena, as can be seen from the large number of international conferences having a multi-wavelength character,” Prof Meintjes said.


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