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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

Mathematical methods used to detect and classify breast cancer masses
2016-08-10

Description: Breast lesions Tags: Breast lesions

Examples of Acho’s breast mass
segmentation identification

Breast cancer is the leading cause of female mortality in developing countries. According to the World Health Organization (WHO), the low survival rates in developing countries are mainly due to the lack of early detection and adequate diagnosis programs.

Seeing the picture more clearly

Susan Acho from the University of the Free State’s Department of Medical Physics, breast cancer research focuses on using mathematical methods to delineate and classify breast masses. Advancements in medical research have led to remarkable progress in breast cancer detection, however, according to Acho, the methods of diagnosis currently available commercially, lack a detailed finesse in accurately identifying the boundaries of breast mass lesions.

Inspiration drawn from pioneer

Drawing inspiration from the Mammography Computer Aided Diagnosis Development and Implementation (CAADI) project, which was the brainchild Prof William Rae, Head of the department of Medical Physics, Acho’s MMedSc thesis titled ‘Segmentation and Quantitative Characterisation of Breast Masses Imaged using Digital Mammography’ investigates classical segmentation algorithms, texture features and classification of breast masses in mammography. It is a rare research topic in South Africa.

 Characterisation of breast masses, involves delineating and analysing the breast mass region on a mammogram in order to determine its shape, margin and texture composition. Computer-aided diagnosis (CAD) program detects the outline of the mass lesion, and uses this information together with its texture features to determine the clinical traits of the mass. CAD programs mark suspicious areas for second look or areas on a mammogram that the radiologist might have overlooked. It can act as an independent double reader of a mammogram in institutions where there is a shortage of trained mammogram readers. 

Light at the end of the tunnel

Breast cancer is one of the most common malignancies among females in South Africa. “The challenge is being able to apply these mathematical methods in the medical field to help find solutions to specific medical problems, and that’s what I hope my research will do,” she says.

By using mathematics, physics and digital imaging to understand breast masses on mammograms, her research bridges the gap between these fields to provide algorithms which are applicable in medical image interpretation.

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