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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

Ensure your place at the UFS
2010-10-27

The University of the Free State (UFS) appeals to all prospective South African students who want to come and study at the UFS in 2011 to submit their applications no later than Tuesday, 30 November 2010.

The UFS is aware of the fact that learners will not have received their final Grade 12 results by Tuesday, 30 November 2010; therefore provisional admission will be granted based on learners’ most recent Grade 12 results. Final admission will take place upon receipt of the final Grade 12 results, which will be available early in January 2011.

Prospective students can obtain application forms for admission at the following places:

  1. The UFS’s web site at www.ufs.ac.za,
  2. The Information Office (Unit for Prospective Students) at the Thakaneng Bridge on the UFS’s Main Campus in Bloemfontein,
  3. You may also send an e-mail to info@ufs.ac.za or
  4. Phone 051 401 3000 and the necessary forms will be posted to you.

Senior undergraduate students (that is all students who were registered up to and during 2010 at the UFS) as well as post-graduate students, must self-register electronically on-line from Monday, 1 November 2010 until Tuesday, 4 January 2011. This includes master’s and doctoral students.

In order to encourage senior students to register online, the UFS offers 20 laptops as incentives for the senior students who successfully register online from 1 November 2010. These laptops will be handed over to the winners after the registration process in 2011.

Registration of first-year students:

The Rector and Vice-Chancellor, Prof. Jonathan Jansen, will welcome first-year students on Friday, 14 January and Saturday, 15 January 2011, respectively, in the Callie Human Centre. The Faculties of Economic and Management Sciences, the Humanities and Education will be welcomed on 14 January 2011 and the students of the Faculties of Natural and Agricultural Sciences, Law and Theology shall be welcomed on 15 January 2011. The compulsory orientation programme for new first-years will also then commence.

From 17 to 21 January 2011 first-year students will receive academic advice at the Callie Human Centre, whereafter they will be referred for self-registration. These processes will take place according to the set timetable. This timetable is available in the Kovsie Guide that will be sent to learners as soon as we have received their applications, as well as on the web site of the UFS at www.ufs.ac.za/register2011.

First-year students’ fees must be paid prior to arrival on 14 and 15 January 2011.

Registration of senior students:

Senior students who experience problems with the electronic on-line self-registration process have the opportunity to resolve problems within a programme on campus from Wednesday, 5 January until Wednesday, 12 January 2011. This programme will be sent out to students and is also available at www.ufs.ac.za/register2011. The specific scheduled day for senior students to resolve problems is the last and only day to resolve the problem.

Senior students can also contact 051 401 9111 for more information in this regard.

Students may register for prescribed modules for 2011, even though the November 2010 examination results are not yet available. Changes resulting from examination results that are made available later can be done up to and including 28 January 2011.

In terms of applications for senior students, only students who have interrupted a calendar year of study need to re-apply for admission.

Registration of students at the UFS’s Qwaqwa Campus:

Senior and first-year students of the UFS’s Qwaqwa Campus register from Wednesday, 12 January until Friday, 28 January 2011 in the Nelson Mandela Hall on this campus.

Registration of students at the UFS South Campus:

First-year students from the UFS’s South Campus in the University Preparation Programme and the Extended Programme (only Natural and Agricultural Sciences) register from Monday, 24 January till Friday, 28 January 2011 in the Arena Hall on the South Campus.

Students who have successfully completed the University Preparation Programme register with the first-year students on the UFS Main Campus on Friday, 14 and Saturday, 15 January 2011 – according to faculties (cf. paragraph 6).

Lectures for all students shall commence on Monday, 24 January 2011.

MEDIA RELEASE
Issued by: Lacea Loader
Director: Strategic Communication (actg)
Tel: 051 401 2584
Cell: 083 645 2454
E-mail: loaderl@ufs.ac.za
26 October 2010

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