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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 13,35%
2008-11-13

 

At the signing of the salary agreement were, from the left: Prof. Johan Grobbelaar, Chairperson of UVPERSU, Prof. Teuns Verschoor, Acting Rector of the UFS, and Ms Senovia Welman, Chairperson of NEHAWU.
Photo: Anita Lombard

UFS staff get salary adjustment of 13,35%

The University of the Free State’s (UFS) management and trade unions have agreed on an improvement in the service benefits of staff of 16,55% for 2009. This includes a general salary adjustment of 13,35% (according to the estimated government subsidy that will be received in 2009).

“The negotiating parties agreed that adjustments could vary from a minimum of 13,00%, or more, depending on the government subsidy and the model forecasts. If the minimum of 13,00% is not affordable, the parties will re-negotiate,” said Prof. Teuns Verschoor, Acting Rector of the UFS.

“The negotiations were conducted in a positive spirit and the parties are in agreement that it is an exceptionally good adjustment – being higher than for example the increase in medical premiums,” said Prof. Verschoor.

The agreement was signed yesterday by representatives of the UFS management and the trade unions, UVPERSU and NEHAWU.

An additional once-off non-pensionable bonus of R3 390 will also be paid to staff later this year.

The bonus will be paid to all staff members who were in the employ of the UFS on UFS conditions of service on 10 November 2008 and who assumed duties before 1 October 2008. This includes all former Vista staff, regardless of whether they have already been aligned with UFS conditions of service.


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 important to note that this bonus can be paid due to the favourable financial outcome of 2008,” said Prof. Verschoor.

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 has as a point of departure that the UFS must be and remain financially sustainable.

Additional funding (0,70%) was also negotiated. This will be allocated on 1 January 2009 to accelerate the phasing-in of medical benefits and, if possible, to finalise the phasing-in process. Agreement was reached that 2,50% 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, as well as the incorporation of Vista staff.

The agreement also applies to all staff members of the two above-mentioned campuses whose conditions of employment have already been aligned with those of the Main Campus.

The implementation date for the salary adjustment is 1 January 2009. The adjustment will be calculated on the total remuneration package.

In 2008, a total improvement of service benefits of 9,32% and a salary adjustment of 7,52% were paid to employees. Staff received a once-off non-pensionable bonus of R3 000 at the end of 2007.

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  
12 November 2007
 

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