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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 awards centenary bonuses to staff
2004-11-25

The University of the Free State (UFS) will award a special Centenary bonus of R3000 (three thousand rand) to all qualifying staff in December 2004 .

As far as general salary increases for 2005 are concerned, plus an inflation- based linked salary increase adjustment of 1,4 percent and a further 4,6 percent salary increase as a final dividend from the financial turn-around strategy that began in 2000, will be instituted .

  • The final percentage salary increase is dependent on whether the expected government subsidy, of which the UFS must still receive notification from the Department of Education, is received.
  • , if the expected government subsidy realizes .
  • In addition, the salaries of service workers in low remuneration groups, as well as full professors have been adjusted retroactively to 1 January 2004. This restructuring was agreed upon to address market-related backlogs for these two groups , who display the biggest backlog relative to comparable institutions . A similar professional bench-marking exercise for support service staff has not been finalised.

This agreement was signed on Wednesday 24 November 2004 between the UFS Council and the UVPERSU-NEHAWU Joint Forum regarding salary negotiations for 2005.

“With this Centenary bonus and the significant above-inflation salary increase payment the UFS wants to pay recogni se tion to the sterling role that staff

have played in a difficult period of transition and fast growth and the contributions that they made to promote excellence at the UFS to a

university of excellence,” said Prof Frederick Fourie, Rector and Vice-

Chancellor of the UFS.

He said that the extra payment of this final 4,6 percent increase due to benefit from the financial turn-around strategy means that in real terms average salaries at the UFS had increased over the past 3 to 4 years by well over more that the 15 percent target that was set initially.

According to Prof Fourie all staff members who were in the employ of the UFS on UFS conditions of service on 15 November 2004 and who assumed duties before 1 October 2004, will qualify for the bonus. The same criteria will apply as for the 2004 bonuses.

However, there are some exceptions who do not qualify for the bonus eg learning facilitators, professors extraordinary, affiliated lecturers, departmental assistants, laboratory assistants, student help, all staff appointed for less than 20 hours per week, persons who are paid on a claims basis etc.

“Although the UFS’s actual subsidy amount is not yet known, an increase of 6,6 % in the total remuneration costs was budgeted for in the budget serving before the Executive Management and Council. It was further agreed with the UVPERSU-NEHAWU Joint Forum that the first 6 % increase will be used as general pensionable salary adjustment with implementation date 1 January 2005,” said Prof Fourie.

According to Prof Fourie the agreement also applies to all staff members of the Qwaqwa and Vista campuses whose conditions of service are already aligned with those of the main campus.

Media release
Issued by: Lacea Loader
Media Representative
Tel: (051) 401-2584
Cell: 083 645 2454
E-mail: loaderl.stg@mail.uovs.ac.za
25 November 2004

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