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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

SRC elections: A first for UFS main campus
2005-08-14

Students on the main campus of the of the University of the Free State (UFS) will this week for the first time vote for the Student Representative Council (SRC) using two voting systems: proportional representation (PR) and first-past-the-post. 

According to the Vice-Rector, Student Affairs, Dr Ezekiel Moraka, this year’s elections are a milestone for the UFS as it will be the first time that the main campus SRC will be elected according to the amended SRC constitution, which was approved by the UFS Council in June 2005.

“It is also a major breakthrough for student governance and transformation of the UFS main campus and constitutes a legitimate basis for the democratic participation of all students at the UFS main campus in the governance of the university,” said Dr Moraka.

The amended constitution of the main campus SRC determines that nine of the 18 SRC members must be elected by means of proportional representation and nine on the basis of an individual, first-past-the-post election.
 
According to Dr Moraka, the introduction of the proportional representation system follows earlier calls by some student formations, notably Sasco and the ANC Youth League, for such a system to be introduced at the UFS main campus in Bloemfontein.

The new main campus SRC constitution is the result of consensus reached during a lengthy negotiation process involving diverse student formations such as Sasco, the ANC Youth League, the Young Communist League, the ACDP, HEREXVII, KovsieAlliance, as well as the democratically elected SRC members of the main campus.

“Independent persons such as Mr Jack Klaas and Mr Kobus van Loggerenberg, a former SRC President, facilitated the negotiation process,” said Dr Moraka.

Students on the main campus in Bloemfontein will vote for a new SRC on Monday 15 August 2005.

SRC elections will also take place on the other two campuses of the UFS, which have their own SRC structures.

Students on the UFS-Vista campus in Bloemfontein will vote for a new SRC on Monday 15 August 2005 and Tuesday 16 August 2005.

At the Qwaqwa campus of the UFS, students will vote for a new SRC on Friday 26 August 2005.

The election processes on all three campuses will be closely monitored by independent electoral bodies. 

After the three campuses have elected their respective SRCs a central SRC will be constituted.  The central SRC will have 12 members made up of delegates of the three campus SRCs, including the presidents of these three SRCs. The main campus will have five representatives, the Qwaqwa campus will have four representatives and the Vista campus will have three representatives.

Main campus voting schedule:
Monday 15 August 2005 from 07:00-21:00.  Ten voting stations will be set up across the campus.  The results will be announced on Tuesday 16 August 2005.

Vista campus voting schedule:
Monday 15 August 2005 and Tuesday 16 August 2005 from 09:00-18:00 in the administration building.  The results will be announced on Wednesday 17 August 2005.
 
Qwaqwa campus voting schedule:
Friday 26 August 2005 from 09:00-18:00 in the Senate Hall.  If there is no objection to the final results, it will be announced on the same day.


Media release

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

14 August 2005
 

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