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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

“Every journey begins with the first steps” – Marguerite van der Merwe
2016-07-08

Description: Marguerite van der Merwe Tags: Marguerite van der Merwe

Marguerite van der Merwe, recipient of University of the
Free State Chancellor’s Medal, with Chancellor
Dr Khotso Mokhele, at the Winter Graduation ceremony.

Photo: Johan Roux

Marguerite van der Merwe has dedicated her life to the enrichment and increased quality of life for others. At the University of the Free State’s Winter Graduations on 30 June 2016, Van der Merwe and her brother, Anthony Douglas Osler, were both honoured with Chancellor’s Medals for exceptional service to South Africa and the world beyond our borders. In the early 1980s, she learned about the Alexander Technique and her life since then has been about perfecting the technique and sharing it with others. The Alexander Technique teaches people of any age, gender, occupation or interest, how to be posture-aware and perfect, how to be aware and alert, and how to be calm and discriminating, all of which are part of a practical teaching to integrate these qualities consciously into all our daily human activities.  

She walks the walk

She understood the Alexander Technique to be the perfect way to develop the body both physically and mentally, as it develops the higher mental faculties like focus, attention, awareness, consciousness, discrimination, and unfolding of the psyche, thus developing the human potential holistically as a spiritual way of being. She received her training for the technique in Cape Town and London, thereafter she published The Art of Walking, a guide to the Alexander Technique.

Van der Merwe is an internationally-certified teacher of the Alexander Technique, has been offering this work and its application in the spheres of health, education, and performance skills for 30 years, both nationally and internationally.

Van der Merwe says that the South African higher education system should encompass a holistic approach to teaching and educating. Education should envisage a modern vision of education that supports the evolution of the potential of the human being as a holistic system – a competent, skilled, caring, kind individual, developed in physical, mental, emotional and sensorial aspects. She believes that students thus educated will model ‘wholeness’ and ‘humanness’ as they take their place in society, business, education, and entrepreneurship.

Enriching women’s potential

Apart from The Art of Walking, Van der Merwe published EVE-OLUTION, a book to inspire women to listen to their intuition, and empower women to repossess their bodily wisdom, freedom, and authenticity. Van der Merwe proclaims that it is important to liberate women to take charge of their own bodies, minds, and souls. The purpose of the book is to ensure that young women soak up wisdom and encouragement and for older women to express their wisdom, which needs to be respected and listened to.

“Females and feminine roles in society and family are being liberated and acknowledged in the actions of many women as we stand for equal opportunity, equal power, and equality in many fields,” says Van der Merwe.
“Our young women in business and the higher education fraternity, for one, are strong in their views, beautiful in their presence, outspoken in leadership,” Van der Merwe concluded.

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