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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

National accolade for Dr Philemon Akach
2013-10-21

 

Dr Philemon Akach
Photo: Sonia Small
21 October 2013


Excellence in Teaching and Learning is highly regarded at the University of the Free State, with our academics recognised on national and international platform.

Earning yet another accolade for the university, Dr Philemon Akach, Head of the Department of South African Sign Language, has been awarded a National Excellence in Teaching and Learning Award. The award by the Higher Education Learning and Teaching Association of Southern Africa (HELTASA) and Council on Higher Education (CHE), recognised Dr Akach as a “leader in the field of teaching and learning – with impact beyond the classroom and the institution.” Recognising his pioneering work within deaf education, HELTASA and CHE commend Dr Akach as an “inspirational practitioner who recognises the inclusion of the marginalised in education.”

Dr Akach is one of five recipients, selected out of a total of 22 candidates from across South Africa that will receive the award. The other winners are from the University of Cape Town, Stellenbosch University, University of KwaZulu-Natal and the University of Pretoria. The five winners will receive the awards at a gala dinner at the annual HELTASA conference, which takes place from 26 to 29 November 2013.

Dr Akach, who will retire at the end of 2014, says the national recognition is the cherry on top as he prepares to return to his home country. Kenya. “How good can it be?” “This is my life calling,” he said about the 37 years he worked within deaf education.

The academic also received an Alumni Award for Outstanding Service at the recent Kovsie Alumni Awards.

Pioneering work by Dr Akach:

  • With Dr Akach steering the process, the UFS became the first university on the continent to offer Sign Language as an academic course in 1999.
  • Dr Akach was part of a nine-member task team that handed over the South African Sign Language (SASL) curriculum to the Minister of Basic Education, Angie Motshekga. A member of the ministerial task team since 2009, he helped to coordinate the development of the curriculum that will soon be offered as a school subject to Grade 0–12 learners in all 42 schools for the deaf in South Africa.

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