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 responds on the outcome of the court case in the alleged attack by Cobus Muller and Charl Blom on Gwebu
2014-09-09

The management of the University of the Free State (UFS) acknowledges the finding issued on 4 September 2014 by the South African Human Rights Commission (SAHRC) that it was “unable to find any corroborating evidence to make a conclusive finding of racism and violation of human rights” in the Muzi Gwebu case.

The university management also takes cognisance of the ruling in the Bloemfontein Regional Court by Regional Magistrate Rasheed Matthews today (9 September 2014) that both Cobus Muller and Charl Blom are found not guilty on all the charges which included reckless driving, crimen injuria, attempted murder and assault (Muller), and a charge of assault (Blom). We note the Magistrate’s concerns about “inconsistencies in the evidence and exaggerations”, that the complainant “displayed hostility throughout the trial” and that he was “not a reliable witness and is prejudiced.” And therefore, in the words of the Magistrate to the defendants, “I’ve decided to give you the benefit of the doubt.”

Both Muller and Blom were suspended from all campuses of the UFS on 19 February 2014 based on the evidence available at the time of reckless driving, assault and other charges. This evidence was further borne out by an internal investigation into the incident of 17 February 2014 on the Bloemfontein Campus. In the light of the evidence available to us at the time, and the volatile situation on campus in the days following the attack, the UFS management believes that it was the correct decision to suspend the students, given the serious nature of the charges, and pending a decision of the courts.

In the light of both the SAHRC ruling as the Regional Court ruling, the university management has decided to take the following steps:

1.    The suspensions of both Muller and Blom from all campuses of the university are lifted with immediate effect.

2.    Muller may attend a forthcoming graduation ceremony during which the degree BSc Construction Management will be officially conferred upon him. He completed all the requirements for the degree in 2013, but was not allowed to attend the graduation ceremony of 11 April 2014 due to his suspension and the fact that the criminal charges were still pending.

3.    Blom may return to the university to complete his studies.

4.    The UFS is in discussion with the parents of one of the students and, if required, would also meet with legal counsel of the university, as well as those of students Muller and Blom to discuss any further steps given the outcome of the court case.

5.    In short, on grounds of the ruling by die SAHRC, as well as the Bloemfontein Regional Court, the university will not continue with its disciplinary action against Muller and Blom.

Prof Jonathan Jansen, Vice-Chancellor and Rector of the UFS said: “This has been a very difficult time for the university and I am pleased to record that throughout the crisis, the student body on the Bloemfontein Campus showed remarkable restraint and discipline, confirming also the broad, non-racial character of the peaceful protests that followed. Our student body has matured and our campus cultures are much more inclusive and transformed as a result of the quality and depth of student leadership over the past few years. The new Student Representative Council (SRC) is a splendid example of this – with the first black woman President (Mosa Leteane) and the first blind woman SRC student leader (Louzanne Coetzee).”

“I am pleased that the matter is now behind us and, again, we rest with the decisions of the Commission and the Courts as final,” he said.

Prof Jansen also apologised on behalf of the UFS to Cobus Muller and Charl Blom, their parents, and their families, for the disruption that the suspension brought in their lives and for the stress they had to bear during this difficult period. “For that, I am truly sorry,” he said.


Issued by: Lacea Loader (Director: Communication and Brand Management)
Tel: +27 (0) 51 401 2584 | +27 (0) 83 645 2454
E-mail: news@ufs.ac.za

 

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