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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 to get a minimum of 4,71 percent salary increase
2005-11-25

The University of the Free State (UFS) management and trade unions have agreed on a minimum of 4,71 percent salary increase for 2006 as well as a once-off non-pensionable bonus of R1200 payable in December 2005.

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

Prof Niel Viljoen, Chief Director: Operations at the UFS and chairperson of the UFS Council’s representatives, and Prof Johan Grobbelaar, chairperson of the joint Union Forum, said: “The bonus is payable in December 2005 in recognition of the role that staff played during the year to promote the UFS as a university of excellence.”

He said the intention is 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.

Proff Viljoen and Prof Grobbelaar said one of the factors that influence the model and therefore the negotiations is the level of subsidy the UFS receives from the government.

“As the state subsidy level is unfortunately not yet known, remuneration could vary several percentage points between a window of 4,71 and 5,5 percent. Should the state subsidy be such that the increase would fall outside this window then the parties will renegotiate.”

Proff  Viljoen and Prof Grobbelaar said the R1200 bonus is payable to staff members who were in the employ of the UFS on UFS conditions of service on 21 November 2005 and who assumed duties before 1 October 2005. There are however some exceptions.

The agreement signed today also provides for restructuring funds of R752 000 to address partial backlogs in support services, including an increase in the medical allowance of 640 staff members.

The implementation date for the salary adjustment is 1 January 2006, but could be implemented on a later date due to logistical arrangements.

Proff Viljoen and Prof Grobbelaar said the UFS and unions could reach an agreement despite the declining phase in income and the generally more difficult financial environment in which universities operate.

Prof Grobbelaar said salary negotiations are never easy, but the model is an important tool. The model made it possible to tie up salary negotiations for November 2006. “This is unique for any higher education institution.”

Media release
Issued by: Lacea Loader
Media Representative
Tel:  (051) 401-2584
Cell:  083 645 2454
E-mail:  loaderl.stg@mail.uovs.ac.za
24 November 2005

 

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