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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

UFS receives record number of applications
2011-12-31

The University of the Free State (UFS) is looking forward to the start of the new academic year in January 2012, when thousands of new students will be joining the Kovsie family.

The UFS received almost 13 000 applications for studies in 2012. This is an increase of about 80% compared to the total number of applications received in 2010 for studies in 2011.

This increase is partly attributed to the university’s new method in approaching prospective students and the marketing initiatives followed during 2011. These included visits to various schools in the country by the Vice-Chancellor and Rector, Prof. Jonathan Jansen.

“This shows that the UFS is becoming a preferred place of study. Unfortunately, we can only take in about 4 000 first-years from these applications. We will, of course, choose the best and most diverse class of students,” says Prof. Jansen.

The university’s marketing initiatives will be intensified next year where students will take part as ambassadors in the university’s student recruitment campaigns for 2013.

Mr.Rudi Buys, The Dean of Student Affairs at the UFS, says Prof. Jansen’s visit to various schools in the country was very successful. This will be continued in 2012 and student leaders from residences, associations as well as the Student Representative Council will accompany him on these visits during the course of the year.

“These learners, just like our students, are part of a new generation of new democratic South Africans. Our students are excellent examples of youth leadership in the country and we are very excited about all our initiatives,” Mr Buys said.

The UFS is aware of the fact that learners will only receive their final Grade 12 results in January 2012. Final admission will therefore only be granted upon the submission of a certified copy of the matriculation results. Fax these results to 086 586 8947 or e-mail to applications@ufs.ac.za  as soon as it is available.

Important dates for Bloemfontein students

  • Friday and Saturday 13 & 14 January 2012: Welcoming of new first-years
  • Sunday 15 January: Gateway College life programme (Bloemfontein edition) begins)
  • Monday 16 January 2012: Registration starts 

Important dates for Qwaqwa students

  • Thursday 12 January 2012: Arrival of first-years
  • Friday 13 January 2012: Gateway College Life programme (Qwaqwa edition) begins.
  • Monday 16 January 2012: Registration starts

For more information, Bloemfontein students can contact Student Affairs at 051 401 9102 or send an e-mail to Cornelia Faasen at faasenc@ufs.ac.za . Qwaqwa students can contact Dulcie Malimabe at 058 718 5018 or send an e-mail to malimabedp@qwa.ufs.ac.za  

Media Release
Issued by:
Lacea Loader
Director: Strategic Communication
Telephone: +27 (0) 51 401 2584
+27 (0) 83 645 2454
E-mail: news@ufs.ac.za
Fax: +27 (0) 51 444 6393
Web: www.ufs.ac.za
 

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