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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 breakthrough on SRC
2005-06-10

The Council of the University of the Free State (UFS) today unanimously approved the establishment of a Central Student Representative Council (CSRC)  to ensure the democratic participation of students at its three campuses in the governance of the university.

In a major breakthrough and transformation step for student governance, the Central SRC will include representatives of the main campus in Bloemfontein, the Vista campus and the Qwaqwa campus of the UFS.

The establishment of the Central SRC follows the incorporation of the Qwaqwa campus into the UFS in January 2003 and the incorporation of the Vista campus in Bloemfontein into the UFS in January 2004.

According to Dr Ezekiel Moraka, Vice-Rector: Student Affairs, today’s decision of Council is the result of a lengthy, negotiated agreement between the three campuses. Independent experts facilitated part of the process.

With the establishment of a Central SRC, the UFS has adopted a federal student governance model whereby the CSRC is the highest representative student body on matters of common concern for all students.

However, the three campuses of the UFS will retain autonomous SRC structures for each campus with powers and responsibilities for matters affecting the particular campus.

This arrangement will be reviewed after a year to make allowance for the phasing out of students at the Vista campus, as was agreed in the negotiations preceding the incorporation of that campus into the UFS.

The central SRC will have a maximum of 12 members made up of members of the campus SRCs, including the presidents of these three SRCs. In total, the main campus will have 5 representatives, the Qwaqwa campus will have 4 representatives and the Vista campus will have 3 representatives.

From these 12 members a central SRC president will be chosen on a quarterly basis to represent the general student body at Executive Management, Senate and Council.

In another key decision and significant step forward affecting student governance, the Council also approved amendments the constitution of the Student Representative Council (SRC) of the main campus.  These amendments were the results of deliberations of student organizations, the SRC and the Student Parliament of the UFS main campus.

The amendments to the 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.

This decision comes in the wake of calls by certain student organizations on main campus for proportional representation to be included as a means of electing student representatives.

The following portfolios of the main campus SRC will be contested by individual candidates on the basis of first past the post:

  • president
  • secretary
  • academic affairs
  • legal and constitutional affairs
  • student development
  • arts and culture
  • men’s internal liaison
  • ladies internal liaison
  • media, marketing and liaison

The following nine portfolios will be contested by affiliated organizations on a proportional representation basis.

  • two vice-presidents
  • treasurerdialogue and associations
  • transformation
  • campus affairs and recreation
  • sport
  • international affairs
  • community service

It also is a breakthrough to have all constitutional changes processed and approved at the June meeting of the Council, with all relevant student organizations having been part of the process and accepting the outcome of the process.

According to the chairperson of the UFS Council, Judge Faan Hancke, today’s unanimous decisions on student governance are an indication of how all UFS stakeholders represented in Council are committed to finding win-win solutions in the interest of the university.

“Once again the UFS has reached another milestone in its transformation and has shown the rest of the country that we are pioneers in the field of reaching intelligent solutions to complex situations,” Judge Hancke said.

According to Dr Moraka, the central SRC constitution will come into effect from the start of the second semester this year.

 MEDIA RELEASE

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

10 June 2005
 

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