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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

Graduates should make a difference as leaders and be agents of change
2017-06-22

Description: Mid-year graduation read more 22 June 2017 Tags: Mid-year graduation read more 22 June 2017

More than 5 000 degrees will be conferred over six days
and eleven ceremonies at the UFS mid-year graduation
ceremonies.
Photo: Johan Roux

Livestream of Graduation Ceremonies

“Make the choice to make a difference as the leaders of the future.” These words of Dr Susan Vosloo, Cardiothoracic Surgeon and member of the University of the Free State (UFS) Council, echoed the call to graduates on the first three days of the UFS mid-year graduation ceremonies. The ceremonies are taking place in the Callie Human Centre on the Bloemfontein Campus from 19 to 26 June 2017.

Dr Vosloo, also an alumna of the UFS, was one of six guest speakers at the biggest set of graduation ceremonies in the university’s history. A spirit of excitement is part of the festivities, as a total of 5 258 degrees will be conferred over six days in eleven ceremonies. The graduation week will conclude on 26 June 2017, when 460 master’s and doctoral degrees will be conferred – 72 of these are doctoral degrees.

Stand up and be counted
Dr Vosloo urged the graduands at the afternoon session on 19 June 2017 to stand up and be counted. “What we need are leaders who treasure integrity, dignity, accountability, transparency, and who will focus on the common challenges which we all face today.”

Dr Khotso Mokhele, UFS Chancellor, also encouraged the graduates to be agents of change who shouldn’t conform to the current system. “Decide that it is your country and that you will decide what it should be. Then it will not be the corrupt experiment which the current government turned it into. We wish you well. Go and be the agents of transformation.”

Ambassadors of the UFS
Prof Francis Petersen, UFS Rector and Vice-Chancellor, asked the graduates to make a contribution: “Be excellent ambassadors of the UFS, and make the UFS, your families, and our country proud by your strong, innovative, ethical, and excellent contributions.” He was the guest speaker during the morning and afternoon sessions on 20 June 2017.

He also said that they should never forget the supporting role others played in their success, whatever form it took.

Do it for those who fought for SA
Justice Connie Mocumie, Judge of Appeal at the Supreme Court of Appeal, encouraged the graduates to go out and contribute to the development of the country. She was the guest speaker at the morning and afternoon ceremonies on 21 June 2017.

“It is important for you to continue being experts in your area of expertise,” she said.

“Today is the beginning of better days to come. Do it for the legacy of those who fought for our country in pursuit of a better South Africa.”

Dipiloane Phutsisi, Principal and Chief Executive Officer of the Motheo TVET College in the Free State, said everyone is destined for greatness. “In the words of Dr Martin Luther King: Everyone has the power for greatness, not for fame but greatness, because greatness is determined by service.” She was the guest speaker at the morning session on 19 June 2017.

Click here to see a list of Deans’ and Senate medals awarded.

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