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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

A magnificent Winter Graduation Ceremony
2013-06-27

 

28 June 2013
Photo: Johan Roux

   Winter Graduation video (YouTube)

The way to immortalise a person, is to live by his example. PhD and master's graduates were imbued by the following message from Dr Khotso Mokhele, Chancellor of the University of the Free State (UFS), during the UFS Winter Graduation Ceremony: to follow Nelson Mandela's majestic example is to guarantee that his life was not in vain.

Dr Mokhele honoured the graduates for their achievements "that clearly did not come easy", referring to the sacrifices on their part and the role of their support structures.

He also praised members of the UFS' leadership team who contributed academically to the excellent standards. Prof Teuns Verschoor, former Vice-Rector: Institutional Affairs, and Prof Driekie Hay, Vice-Rector: Academic, were especially mentioned for their role as respectively co-promoter and promoter of two PhD graduates.

A total of 63 doctorates and 414 master's degrees were awarded to graduates from South Africa, Nigeria, Lesotho, Uganda and Zimbabwe on Thursday 27 June 2013.

On the previous day, the School of Open Learning kicked off the graduation event by conferring 320 qualifications.

The graduates, most of them full-time educators, received qualifications ranging from certificates to diplomas.

"I hope that you will plough back what you have learned and that this qualification will make you a better educator, an inspired one, one that will relentlessly put your efforts into increasing a better future for our children," Prof Hay said, highlighting challenges in South Africa's education system.

"Become enthused, obsessed and passionate to change the education system. Be the change agent in your schools to contribute in giving the quality education our children so desperately need," she said.

An exceptional moment at this year's graduation ceremony was when the two daughters of an academic, Prof Dave Lubbe of the Centre for Accounting, obtained their master's degrees. "It is indeed a highlight in my career that my daughters received their master's degrees cum laude at the same graduation ceremony, under my supervision!"

Prof Lubbe's two daughters, Nandi Lubbe and Leandi Steenkamp, both received their MCom with distinctions in Accounting. They completed their degrees under the supervision of Prof Lubbe and Nandi also won the Dean's medal as the best M student in the Faculty of Economic and Management Sciences.

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