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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 helps to renovate schools
2005-10-10

Photo gallery

About 250 hostel students of the University of the Free State's (UFS) main campus yesterday painted and renovated four schools in the black townships of Bloemfontein.  This was part of Kovsie Rag's new approach to be more directly involved with communities.

Students were transported with busses and performed tasks such as the painting of class rooms and outside walls and the cleaning and painting of gutters and window panes.  The painting was judged by a panel of judges, that included the Rector and Vice-Chancellor, Prof Frederick Fourie.  These points will contribute to the each hostel's final point in the Rag fund raising campaign for 2005/2006.

 

 

Some of the students who painted the gutters of Maboloka Primary School in Bochabelo were from the left Ms Tume Kowang (18) (first year student in B Accounting from NJ van der Merwe hostel); Ms  Gloria Mangwane (19) (third year student in B Sc Biochemy from NJ van der Merwe hostel); Ms Adri Ras (21) (second year student in Occupational Therapy from Emily Hobhouse hostel) and Ms Malandi Els (20) (third year student in B Exercise and Feeding from Emily Hobhouse hostel).

See attached media statement:

UFS Rag and Eimpa paints assist with upgrading of schools

The spirit of Ubuntu will this year be truly reflected in the University of the Free State’s (UFS) Rag community out reach programme when senior students from the 23 hostels on the Main Campus will visit four less-privileged schools in the Mangaung area on Saturday 8 October 2005 to assist these schools in the upgrading of facilities.

The same day (Saturday 8 October 2005) the UFS first year students will visit the neighbourhoods in Bloemfontein from 08:00-13:00 to raise funds on an Ubuntu donation lists for Rag 2005/2006.

The Ubuntu project was started about seven years ago and it has grown each year. In the past the project was associated with a fundraising leg and a hostel publicity leg.  This year the aim is to involve the community to demonstrate how important fundraising initiatives are to help those less-privileged. 
 
The schools that will be visited are Legae Intermediary School in Batho, Mothusi Primary School in Rocklands, and the Maboloka and Lesedi Primary Schools in Bochabelo.  The schools in the Manugaung area had until 31 August 2005 to complete a questionnaire identifying what assistance is needed.  The Rag office, with the help of professional consultants from Eimpa Paints, chose four schools and visited each one to determine material/s needed to complete the work. 

Eimpa Paints is a partner of the Ubuntu project and will be sponsoring all paint necessary to complete the work at the schools.  All other material/s needed will be supplied by the UFS Rag office.

The hostels are divided into project teams and will clean and paint gutters and window sills and paint the walls of classrooms and outside walls.  At Maboloka School for instance, a project team will also to paint a wall with colourful characters.

Media release
Issued by:  Lacea Loader
Media Representative
Tel:  (051) 401-2584
Cell:  083 645 2454
E-mail:  loaderl.stg@mail.uovs.ac.za
7 October 2005

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