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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

Full week of graduation ceremonies at UFS in April
2015-04-10

Autumn always sees the UFS’s first graduation ceremony of the year on the Bloemfontein Campus.

From 14 – 17 April 2015, graduates will once again be rewarded for their hard work while top speakers will address them in the Callie Human Centre. There will be a ceremony at 09:00 and at 14:30 each day on all four days of the graduation.

The programme for the 2015 April Graduation is as follows:

Tuesday 14 April 2015:

Professor Himla Soodyall will be the speaker at both ceremonies on this day. Prof Soodyall is a Medical Scientist for the South African Institute for Medical Research. She is also a Principal Medical Scientist for the National Health Laboratory Service, and a Director for the Human Genome Diversity and Disease Research Unit at the University of Witwatersrand.

During the first ceremony of the day at 09:00, all diplomas/certificates and B degrees in the Faculty of Natural and Agricultural Sciences will be awarded. Only Honours degrees in the Faculty of Natural and Agricultural Sciences will be awarded at the 14:30 ceremony.
 
Wednesday 15 April 2015:

Wednesday will see Ndumiso Hadebe take the stage to address graduates at both ceremonies.

At the age of 23, Hadebe is the Founder and Managing Director of Master Frontiers Consulting, a firm that capacitates leaders and managers to achieve business goals through their people. He worked previously as a Researcher at Shanduka Black Umbrellas, a flagship enterprise and supplier development programme of the Shanduka Foundation. 

He has been received numerous awards for excellence in leadership, such as the Sedibeng District Municipal Mayor’s Award for Service and Leadership. He is a Brand South Africa Ambassador and Read Educational Trust Ambassador.

All diplomas/certificates, B and Honours degrees in the Faculty of Economic and Management Sciences, except B Com degrees, will be awarded during the morning ceremony at 09:00. Later, at the 14:30 ceremony, only B Com degrees in the Faculty of Economic and Management Sciences will be awarded.

Thursday 16 April 2015:

Multiple award winning South African TV presenter, Leanne Manas, will be the speaker at both Thursday ceremonies.

Manas has graced our screens for over a decade. Not many broadcasters can boast having had live TV experience, 5 days a week for 12 years. She is currently the anchor of SABC 2’s flagship breakfast programme, Morning Live. Leanne is a qualified Speech and Drama teacher. having studied at London Trinity College. She also has an Honours degree in English.
Diplomas/certificates up to and including Honours degrees in the Faculty of the Humanities, Social Sciences, and Communication Sciences will be awarded during the ceremony at 09:00. The 14:30 ceremony will have diplomas/certificates up to and including Honours degrees in the Faculty of the Humanities’ other qualifications except for Social Sciences and Communication Sciences.
 
Friday 17 April 2015:

Dr Maria Phalime will be the speaker at both ceremonies on Friday.

Phalime is a medical doctor and award-winning author. She practiced for a brief period as a general practitioner in South Africa and the United Kingdom, before leaving medical practice to pursue non-clinical interests. She has worked in trade and investment promotion, and has undertaken research and consulting in the areas of economic development and business facilitation.

Diplomas/certificates up to and including Honours degrees in the Faculty of Education (CE, NPDE and ACE excluded) will be awarded during the ceremony at 09:00. Diplomas/certificates up to and including Honours degrees in the Faculties of Health Sciences, Law, and Theology will be awarded at the 14:30 ceremony.

Click here for the simple layout of the 2015 April Graduation programme:
http://www.ufs.ac.za/adhoc-pages/2014-graduation-ceremony/graduation-ceremony

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