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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 committed to transformation
2005-02-23

UFS committed to transformation

The management of the University of the Free State (UFS) takes note that plans are being made to stage a student protest at the UFS main campus on Monday 28 February 2005 .

This is in line with a concerted national campaign to highlight the issue of transformation at higher education institutions.

At this stage the UFS management has not received any application from student formations to stage such a protest at the main campus in Bloemfontein .

The UFS upholds the right of all staff and students to hold legal, non-violent protests and in this spirit encourages the student formations to apply for permission to hold their protest. However, the UFS management has been - and always will be willing to discuss the important issue of transformation of the UFS with staff unions and student formations.

Again the UFS management appeals to student formations to make use of this open door policy and not to adopt a confrontational position. In fact the management and the Senate of the UFS have come out in support of a new phase of transformation at the UFS.

In his speech at the official opening of the UFS earlier this month (on 4 February 2005 ), the Rector and Vice-Chancellor, Prof Frederick Fourie, announced that a comprehensive transformation plan for would be drafted for the UFS.

This Transformation Plan would address issues such as:

  • a new institutional culture for the UFS
  • the need for representivity in the staffing of the UFS
  • ensuring relevance of curricula for the South African and African context
  • enhancing excellence in the overall academic life of the UFS
  • ensuring greater interaction among black and white students and staff
  • addressing outstanding issues in the incorporation of the Qwaqwa and Vista campuses, among others

Concerning some of the issues that are being put forward to motivate for a protest march, the UFS would like to highlight the following facts:

  1. The situation at the Qwaqwa campus
  • It is not true that the UFS has decided to close down the Qwaqwa campus. This is a complete falsehood. The campus was incorporated into the UFS in January 2003 and since then every effort is being made to ensure the viability of the Qwaqwa campus.
  • In fact the UFS has just upgraded residences at the Qwaqwa campus – to the tune of R6,8-million.
  • In addition, another R1,4-million has been set aside for the upgrading of other facilities on the Qwaqwa campus.
  • More staff has been appointed and the library is acquiring more books etc.
  • The management of the UFS wants to assure staff at the Qwaqwa campus once again that there has been no decision to close the campus.
  • We realise that the incorporation of the campus into the UFS has given rise to certain fears and concerns, but these are being addressed, including the question of reporting lines of staff and the further delegation of powers to the head of the Qwaqwa campus, Prof Peter Mbati.
  1. The situation at the Vista campus
  • A number of processes are currently under way to address outstanding issues following the formal incorporation of the Vista campus into the UFS in January 2004.
  • This includes the integration of former Vista staff into the UFS as well as the alignment of the conditions of service of the former Vista staff with the UFS conditions of service.
  • Indeed, over the last few weeks, a climate of trust has been developing and a number of meetings have taken place in contrast to the situation that obtained at the end of 2004.
  • Just last week, the Rector reassured the Vista Task Team representing the former Vista staff that these staff members are indeed part of the UFS staff complement.
  • When the Vista campus was incorporated into the UFS, it was agreed that no new first years would be registered there, so as to avoid duplication with the main campus which is only a few kilometers away.
  • Instead, those students who were registered as Vista students at the time of incorporation (January 2004) would be allowed to complete their studies.
  • In terms of this agreement another process of consultation with key stakeholders on and off campus would be initiated to determine how the physical facilities of Vista could be used to contribute to educational and skills provision in the region and the province.
  • This process is still in its early stages and no final decision has been made regarding the long term strategic reconfiguration of the Vista campus.
  • In any case, as stated by the Rector, former Vista staff do not have to fear about their work security as this is not dependent on the future use of Vista campus – the two issues are not related.
  1. Financial aid for students at the Qwaqwa campus
  • Concerning financial aid to students at Qwaqwa, the UFS has to date (that is up to 22 February 2005 ) made available R25 000 each to 705 students.
  • That amounts to R17,6 million.
  1. Financial aid for students at the Vista campus
  • Concerning financial aid to students at Vista , the UFS has to date (that is up to 22 February 2005 ) made available R14 500 each to 104 students.
  • That amounts to R1,5 million.
  1. Registration
  • The registration processes at both these campuses are not yet completed. So final figures are not yet available.
  • What we can say so far, is that 1339 students have registered at the Qwaqwa campus and that more are expected to register. At Vista , 545 students have registered so far, and more are expected to do so.
  • In an effort to assist students during the registration process, management has put in place a structure which is called the Monitoring Committee.
  • This Monitoring Committee provides counseling on courses of study but also sorts out problems relating to academic fees, etc.
  • This is how the UFS management in a concrete way gives expression to its commitment to broadening access for academically deserving students.
  1. Alleged racism
  • There have recently been unsubstantiated allegations of racism leveled at the UFS.
  • We would like to state unequivocally, that the UFS does not and will not tolerate racism in any way.
  • There are policies and procedures in place to deal with such allegations and those who feel aggrieved should bring this to the attention of the Director of Diversity, Mr Billyboy Ramahlele.
  • The UFS also has sensitisation programmes for staff and students to assist in bringing about a truly non-racial, non-sexist, inclusive, multicultural and multilingual campus.

.

  1. Conclusion
  • The UFS management remains committed to the further transformation of the institution so that it can play its role in supporting the goal of a non-racial, democratic South Africa united in its diversity.
  • We are committed to the successful incorporation of the Vista and Qwaqwa campuses and to the speedy resolution of all outstanding issues facing staff and students on these campuses.
  • We appeal once again to staff and students on these campuses, who are indeed members of the broader UFS community, to play a constructive role in the debate about the strategic direction of the UFS and all its campuses.

 

Issued by: Mr Anton Fisher

Director: Strategic Communication

Cell: 072-207-8334

Tel: 051-401-2749

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