Latest News Archive

Please select Category, Year, and then Month to display items
Years
2017 2018 2019 2020
Previous Archive
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 Council adopts guidelines for the development of a new Language Policy
2015-12-04

The Council of the University of the Free State (UFS) adopted the following guidelines from the report by the Language Committee regarding the development of a new Language Policy for the UFS, based on the core values of inclusivity and multilingualism:

  1. that English becomes the primary medium of instruction in undergraduate education and, as largely exists already, in postgraduate education.
  2. that the UFS embeds and enables a language-rich environment committed to multilingualism, with particular attention to Afrikaans, Sesotho, isiZulu, and other languages represented on the three campuses.
  3. that an expanded tutorial system be available to especially first-year students in Afrikaans, Sesotho, isiZulu and other languages, in order to facilitate the transition to English instruction.
  4. that the parallel-medium policy continues in particular professional programmes, given the well-defined Afrikaans markets that, at the moment, still makes such language-specific graduate preparation relevant.
  5. that the language of administration be English.
  6. that the English-medium language policy be implemented with flexibility and understanding, rather than as a rigid rule disregarding the circumstances.

These guidelines were adopted at the Council meeting which took place on the Bloemfontein Campus on Friday 4 December 2015.

“This important and emotive matter was discussed in a high-quality, open debate and I am satisfied with the way the decision was reached,” says Judge Ian van der Merwe, Chairperson of the UFS Council.

The decision by Council comes after a mandate was given to the University Management on 4 June 2015 to conduct a review of the institutional Language Policy. A Language Committee was subsequently established by the University Management Committee (UMC) to undertake a comprehensive review of the existing parallel-medium policy and to make recommendations on the way forward with respect to the university's Language Policy.

The Language Committee conducted a comprehensive consultation process on the future of the Language Policy with all university stakeholders. This included multiple dialogue and submissions sessions, as well as an opinion poll on all three campuses.

Guided by the Council resolution of 4 December 2015, the UFS management will now proceed to design a Language Policy that would be presented to the UMC and Senate for voting purposes again, which vote would be formally presented to Council at one of its governance meetings in 2016. The Institutional Forum, a statutory body that represents all university stakeholders, would also advise Council at that stage, per its mandate, on the new Language Policy.

In the event that a new Language Policy is accepted by Council in 2016, the earliest possible date for implementation would be January 2017.


Related articles:

http://www.ufs.ac.za/templates/news-archive-item?news=6567 (26 November 2015)
http://www.ufs.ac.za/templates/news-archive-item?news=6540 (28 October 2015)
http://www.ufs.ac.za/templates/news-archive-item?news=6521 (20 October 2015)
http://www.ufs.ac.za/templates/news-archive-item?news=6469 (30 August 2015)
http://www.ufs.ac.za/templates/news-archive-item?news=6444 (25 August 2015)

 

 

 

We use cookies to make interactions with our websites and services easy and meaningful. To better understand how they are used, read more about the UFS cookie policy. By continuing to use this site you are giving us your consent to do this.

Accept