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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

Sunflowers are satellite dishes for sunshine, or are they?
2016-07-20

Eighty-six percent of South Africa’s
sunflowers are produced in the
Free State and North West provinces.

Helen Mirren, the English actress, said “the sunflower is like a satellite dish for sunshine”. However, researchers at the University of the Free State (UFS) have found that too much of this sunshine could have a negative effect on the growth of sunflowers, which are a major source of oil in South Africa.

According to Dr Gert Ceronio from the Department of Soil, Crop, and Climate Sciences at the UFS, extremely high soil temperatures play a definite role in the sprouting of sunflower seedlings. Together with Lize Henning, professional officer in the department, and Dr André Nel from the Agricultural Research Council, he is doing research on biotic and abiotic factors that could have an impact on sunflowers.

Description: Sonneblom 2 Tags: Sonneblom 2

Various degrees of deformity (bad-left
to none-right) in seedlings of the same
cultivar at very high soil temperatures.
Photo: Dr Gert Ceronio

Impact of high temperatures on sunflower production

The Free State and North West provinces, which produce 86% of South Africa’s sunflowers, are afflicted especially by high summer temperatures that lead to extremely high soil temperatures.

Dr Ceronio says: “Although sunflower seeds are able to germinate at temperatures from as low as 4°C to as high as 41°C, soil temperatures of 35°C and higher could have a negative effect on the vegetative faculty of sunflower seedlings, and could have an adverse effect on the percentage of sunflowers that germinate. From the end of November until mid-January, this is a common phenomenon in the sandy soil of the Free State and North West provinces. Soil temperatures can easily exceed the critical temperature of 43°C, which can lead to poor germination and even the replanting of sunflowers.”

Since temperature have a huge impact not only on the germination of sunflower seeds, but also on the vegetative faculty and sprouting of sunflower seedlings, Dr Ceronio suggests that sunflowers should be planted in soil with soil temperatures of 22 to 30°C. Planting is usually done in October and early November. Unfortunately, this is not always possible, as soil moisture is not optimal for growth. Farmers are then compelled to plant sunflowers later.

Impact of herbicides on sunflower growth

“High soil temperatures, combined with the herbicide sensitivity of some cultivars, could lead to the poor development of seedlings," says Dr Ceronio.

The use of herbicides, such as ALACHLOR, for the control of weeds in sunflowers is common practice in sunflower production. It has already been determined that ALACHLOR could still have a damaging effect on the seedlings of some cultivars during germination and sprouting, even at recommended application dosages.

“The purpose of the continued research is to establish the sensitivity of sunflower cultivars to ALACHLOR when exposed to high soil temperatures,” says Dr Ceronio.

 

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