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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

FF Plus court case against UFS withdrawn
2007-10-23

The University of the Free State (UFS) is pleased to announce that a Supreme Court application to have the racial integration of its student residences set aside has been withdrawn unconditionally by the Freedom Front Plus (FF+). The political party has offered to pay the assessed costs of the UFS.

The Rector and Vice-Chancellor of the UFS, Prof. Frederick Fourie, welcomed this decision by the FF+, saying all energy should now be focused on making a success of this very important nation-building initiative in the student residences. “We have been convinced all the time that we had followed a fair and inclusive consultation process which led to a thorough and well-considered decision by the Council,” he said.

The decision to integrate student residences as from January 2008 was approved by the UFS Council on 8 June 2007. This last decision was confirmed by the Council – which is the highest decision making body at the UFS -  on 14 September 2007 with an overwhelming majority, with only one vote against.

“There is now no legal obstacle to student participation in the work being done to implement Council’s decision. In fact I want to urge all students in our residences to play an active role in implementing Council’s decision,” he said.

According to Prof. Fourie much work has been done in preparation for the intake of first-years into the residences in January 2008.

Since the initial decision of 8 June 2007, the Vice-Rector: Student Affairs, Dr Ezekiel Moraka, has been leading a team of staff members and student representatives who are doing work in various sub-task teams.

“One of the main reasons for working in this way through sub-task teams, is to ensure the widest possible participation of the affected students in the implementation of the Council’s decision,” said Prof. Fourie.

These sub-task teams are working on aspects of residence life in order to make the racial integration of residences as successful as possible. These aspects of residence life include, among others:
 

  • governance structures
  • traditions and character of residences
  • diversity education and training
  • security
  • placement and recruitment

“This list is not exhaustive, but merely to illustrate the kinds of areas being looked into. I would like to encourage all students in residences to make an input into the work of these sub-task teams through the primes, the Student Representative Council (SRC) or through the offices of the Dean or the Deputy Dean of Student Affairs.

“We have already begun to implement an interpreting service at the house meetings of three ladies residences, namely Emily Hobhouse, Roosmaryn and Vergeet-my-nie. From next year this service will be extended to other residences on the Main Campus,” said Prof. Fourie.  

“In the light of withdrawal of the court case, I am appealing to all students in our residences, to join hands with fellow students and with management in creating a campus of respect and appreciation for all languages, cultures and backgrounds,” he said.

“We want our students to assist the UFS in successfully managing the rich diversity on this campus, particularly in its student residences, and in so doing become an example to South Africa of a truly non-racial, multi-cultural and multi-lingual campus, where students are appropriately educated for the workplace,” Prof. Fourie said.


Media release issued by:        
Lacea Loader
Assistant Director: Media Liaison  
Tel:  051 401 2584
Cell:  083 645 2454
E-mail:  loaderl.stg@ufs.ac.za

23 October 2007

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