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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

Fighting the tuberculosis battle as a collective
2015-09-28



The team hard at work making South Africa a
healthier place

Tuberculosis (TB) is second only to HIV/AIDS as the greatest killer worldwide due to a single infectious agent. More than 95% of TB deaths occur in low- and middle-income countries. Despite being more prevalent among men than women, TB remains one of the top five causes of death amongst women between the ages of 15 and 44 years. While everyone is at risk for contracting TB, those most at risk include children under the age of five and the elderly. In addition, research indicates that individuals with compromised immune systems, household contacts with pulmonary TB patients, and healthcare workers are also at increased risk for contracting TB.

According to the Deputy Director of the Centre for Health Systems Research and Development (CHSR&D) at the UFS, Dr Michelle Engelbrecht, research has found that healthcare workers may be three times more likely to be infected by TB than the general population.

The unsettling fact

“Research done in health facilities in South Africa has found that nurses do not often participate in basic prevention acts, such as opening windows and wearing respirators when attending to infectious TB patients,” she explained. 

In response to this concern, CHSR&D, which operates within the Faculty of Humanities at the the University of the Free State (UFS) Bloemfontein Campus has developed a research project to investigate TB prevention and infection control in primary healthcare facilities and households in Mangaung Metropolitan.

Action to counter the statistics

A team of four researchers and eight field workers from CHSR&D are in the process of gathering baseline data from the 41 primary healthcare facilities in Mangaung. The baseline comprises a facility assessment conducted with the TB nurse, and observations at each of the facilities. Individual interviews are also conducted with community caregivers, as well as TB and general patients. Self-administered questionnaires on knowledge, attitudes, and practices about TB infection control are completed by all nurses and facility-based community caregivers.

Healthcare workers are the main focus of this research, given their increased risk of acquiring TB in healthcare settings. At clinics, interventions will be developed to improve infection control practices by both healthcare workers and patients. TB patients’ households are also visited to screen household contacts for TB. Those found to have symptoms suggesting TB infection are referred to the clinics for further assessment and treatment.

The findings of this study will serve to inform the development of an intervention to address TB prevention and infection control in primary healthcare facilities. Further funding will be sought to implement and evaluate the intervention.

Curbing future infections and subsequent deaths as a result of TB is the priority for the UFS. The cooperation and collaboration of the community, government, and sponsors will ensure that this project is a success, hence prolonging life expectancy.


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