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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

To tan or not to tan: a burning issue
2009-12-08

 Prof. Werner Sinclair

“Some evidence exists which implies that sunscreens could indeed be responsible for the dramatic rise in the incidence of melanoma over the past three decades, the period during which the use of sunscreens became very popular,” says Prof. Werner Sinclair, Head of the Department of Dermatology at the University of the Free State. His inaugural lecture was on the topic Sunscreens – Curse or Blessing?

Prof. Sinclair says the use of sunscreen preparations is widely advocated as a measure to prevent acute sunburn, chronic sun damage and resultant premature skin aging as well as skin malignancies, including malignant melanoma. There is inconclusive evidence to prove that these preparations do indeed achieve all of these claims. The question is whether these preparations are doing more harm than good?

He says the incidence of skin cancer is rising dramatically and these tumours are induced mostly by the ultra-violet rays.

Of the UV light that reaches the earth 90-95% belongs to the UVA fraction. UVC is normally filtered out by the ozone layer. UVB leads to sunburn while UVA leads to pigmentation (tanning). Because frequent sunburn was often associated with skin cancer, UVB was assumed, naively, to be the culprit, he says.

Exposure to sunlight induces a sense of well-being, increases the libido, reduces appetite and induces the synthesis of large amounts of vitamin D, an essential nutritional factor. The use of sunscreen creams reduces vitamin D levels and low levels of vitamin D have been associated with breast and colon cancer. Prof. Sinclair says the 17% increase in breast cancer from 1981 to 1991 parallels the vigorous use of sunscreens over the same period.

Among the risk factors for the development of tumours are a family history, tendency to freckle, more than three episodes of severe sunburn during childhood, and the use of artificial UV light tanning booths. He says it remains a question whether to tan or not. It was earlier believed that the main carcinogenic rays were UVB and that UVA merely induced a tan. The increase in UVA exposure could have severe consequences.

Prof. Sinclair says the UV light used in artificial tanning booths consists mainly of pure UVA which are highly dangerous rays. It has been estimated that six per cent of all melanoma deaths in the UK can be directly attributed to the use of artificial tanning lights. The use of an artificial tanning booth will double the melanoma risk of a person. “UVA is solely responsible for solar skin aging and it is ironical that tanning addicts, who want to look beautiful, are inflicting accelerated ageing in the process,” he says.

On the use of sunscreens he says it can prevent painful sunburn, but UVA-induced damage continues unnoticed. UVB blockers decrease vitamin D synthesis, which is a particular problem in the elderly. It also prevents the sunburn warning and therefore increases the UVA dosage that an individual receives. It creates a false sense of security which is the biggest problem associated with sunscreens.

Evidence obtained from the state of Queensland in Australia, where the heaviest and longest use of sunscreens occurred, boasted the highest incidence of melanoma in the world. A huge study in Norway has shown a 350% increase in melanoma for men and 440% for women. This paralleled the increase in the use of UVB blocking sunscreens while there was no change in the ozone layer. It did however, occur during that time when tanning became fashionable in Norway and there was an increase especially in artificial tanning.

Prof. Sinclair says: “We believe that sunscreen use does not directly lead to melanoma, but UVA exposure does. The Melanoma Epidemic is a reality. Sunscreen preparations are not the magical answer in the fight against melanoma and the irresponsible use of these preparations can worsen the problem.”

Media Release
Issued by: Mangaliso Radebe
Assistant Director: Media Liaison
Tel: 051 401 2828
Cell: 078 460 3320
E-mail: radebemt.stg@ufs.ac.za
7 December 2009

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