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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 staff get salary adjustment of 8,5%
2010-11-03

The University of the Free State’s (UFS) management and trade unions have agreed on a general salary adjustment of 8,5% for 2011. The negotiating parties agreed that adjustments could vary proportionally from a minimum of 7,5% to a maximum of 9,5%, depending on the government subsidy and the model forecasts.

 The service benefits of staff will be adjusted to 10,66% for 2011. This is according to the estimated government subsidy that will be received in 2011.

 The agreement was signed on Friday, 29 October 2010 by representatives of the UFS Management and the trade unions UVPERSU and NEHAWU.

An additional once-off, non-pensionable bonus of R3 000 will also be paid to staff with their December 2010 salary payment. The bonus will be paid to all staff members who were in the employment of the university on UFS conditions of service on 31 December 2010 and who assumed duties before 1 October 2010. The bonus is payable in recognition of the role played by staff during the year to promote the UFS as a university of excellence and as confirmation of the role and effectiveness of the remuneration model.

 It is the intention to pass the maximum benefit possible on to staff without exceeding the limits of financial sustainability of the institution. For this reason, the negotiating parties reaffirmed their commitment to the Multiple-year, Income-related Remuneration Improvement Model used as a framework for negotiations. The model and its applications are unique and have as a point of departure that the UFS must be and remains financially sustainable.

Agreement was reached that 2% will be allocated for growth in capacity building to ensure that provision is made for the growth of the UFS over the last few years. A further 0,16% will be allocated to structural adjustments.

 The implementation date for the salary adjustment is 1 January 2011. The adjustment will be calculated on the total remuneration package.

Prof. Johan Grobbelaar, Chairperson of the UVPERSU and NEHAWU mutual forum, is very pleased with the outcome and good spirit in which the negotiations, “that were concluded in a couple of hours”, took place. The 8,5% increase for 2011 means that for the past ten years the UFS staff has received a 38% increase above inflation in effect. 

 “Not only is this a major achievement in that the staff is much better off, but the salaries compare well with similar institutions in the country,” says Prof. Grobbelaar.

  It is also with nostalgia that the negotiations took place this year, because Prof. Grobbelaar and Prof. Niel Viljoen, Vice-Rector: Operations, both retire in 2011.  Prof. Viljoen was the chairperson of the UFS Council’s negotiation team for the past ten years.

  Media Release
 
Issued by: Lacea Loader
Director: Strategic Communication (actg)
Tel: 051 401 2584
Cell: 083 645 2454
E-mail: loaderl@ufs.ac.za
  3 November 2010
 

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