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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

Significant support for Student Safety March in Bloemfontein
2017-07-28

 Description: Student Safety March Prof Petersen Tags: Student Safety March Prof Petersen 

SK Luwaca, UFS SRC President; Thapelo Ngozo,
CUT SRC President, and Prof Francis Petersen,
UFS Rector and Vice-Chancellor, during the handover of the
memorandum at the Bram Fischer Building.
Photo: Johan Roux

The University of the Free State (UFS) and the Central University of Technology (CUT) united in a Student Safety Awareness March, which took place on Thursday 27 July 2017 from the UFS Bloemfontein Campus to the Bram Fischer Building.

The peaceful march had a turnout of approximately 1 500 students and staff from both institutions, led by the Student Representative Councils (SRC) from UFS and CUT. The purpose of the march was to hand over a memorandum to the Provincial Commissioner, Lieutenant General Lebeoana Tsumane, who acknowledged it on behalf of Mr Sam Mashinini, MEC for Police, Roads, and Transport in the Free State. The memorandum includes students’ demands regarding safety around student residential areas and general student safety in the city.

Prof Francis Petersen, UFS Rector and Vice-Chancellor, who – together with other members of the senior leadership group – was part of the march, says he is very impressed with the outcome of the march and the participation rate of both staff and students, as well as the joint efforts between the UFS and CUT to arrange the march.

Prof Petersen says, “There are public spaces where our students feel unsafe, and we would like the city and the province to seriously look into that and work with us to try and see if we could make those spaces safe.

A week filled with safety activities
The march was part of the Safety Week taking place from 24 to 28 July 2017, during which the UFS SRC, together with other stakeholders, took part in several activities on and off the Bloemfontein Campus. These included door-to-door visits to student homes and residences on and around campus, awareness campaigns at all the gates of the campus, and a Safety Dialogue held on 26 July 2017 at the Equitas Auditorium on campus.

The aim of the Safety Week was to focus on informing, educating, and encouraging students as well as the Mangaung community at large, to work together in creating a safe environment for students. The week started with the roll-out of an awareness campaign titled Reach Out, which was set to bring students and the community of Mangaung together to help decrease the number of violent crimes faced by students off campus. The communication plan included safety messages, using outdoor billboards, posters on lampposts around the residential student areas, local community radio stations, campus media, and the university’s social media platforms.

 Description: Student Safety March  Tags: Student Safety March  

UFS and CUT students and staff, occupying the streets of
Bloemfontein during the Safety March.
Photo: Johan Roux

Accreditation of off-campus accommodation service providers
Over and above the Safety Week and safety awareness march, the university has initiated a number of other projects as part of its student safety strategy. This includes a process to accredit off-campus accommodation service providers in Bloemfontein who provide accommodation to students. The decision to accredit these service providers comes from a concern by the university management about the safety of students and the conditions under which some of our students live in off-campus accommodation. The accreditation process entails a list of primary requirements, drafted with the cognisance of the Mangaung Metropolitan Municipality and the SRC, in terms of off-campus accommodation to which private providers must adhere in order to be accredited by the university. The requirements are in line with the Policy on the Minimum Norms and Standards for Student Housing at Public Universities (Government Gazette 39238, dated 29 September 2015).

Transport to and from campus
Another project to be initiated on 31 July 2017 is a transport pilot project with Interstate Bus Lines to assist students with transport and access to the Bloemfontein Campus. The route includes various stops in the areas surrounding the campus, as well as a hop-on/hop-off route within the campus.


Released by:

Lacea Loader (Director: Communication and Brand Management)
Telephone: +27 51 401 2584 | +27 83 645 2454
Email: news@ufs.ac.za | loaderl@ufs.ac.za
Fax: +27 51 444 6393


 

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