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

All activities on UFS Bloemfontein and Qwaqwa Campuses postponed until Monday 26 October 2015
2015-10-22

All academic and administrative activities on the Bloemfontein and Qwaqwa Campuses of the University of the Free State (UFS) have been postponed until Monday 26 October 2015.

UFS students joined the national protests against the increases in class and study fees at universities across the country on Tuesday 20 October 2015.

All campuses of the UFS were closed down on Wednesday 21 October 2015 and a court interdict was granted the same day against conduct by anyone who intends to damage the property of the university or who interferes with the rights of others.

Additional security measures have been implemented at all residences on the Bloemfontein Campus today, and no acts of violence or intimidation have been reported in residences. The situation on the Bloemfontein Campus grounds is monitored carefully to ensure calmness.

Messages doing the round on social media today that management agreed to a 0% increase in fees in 2016 are not true. The university management are continuously communicating with the Student Representative Council (SRC), while working incessantly to restore peace and stability on the Bloemfontein Campus.

“Although the university management supports the right of students to protest, it has a responsibility towards the university community to ensure the safety of property and people, as well as the rights of other students who do not feel inclined to participate in this movement. The university management calls on non-protesting students to remain calm and to refrain from getting into any confrontation with protesting students. This is a trying time for universities across the country, and the main concern of the UFS management is to maintain stability on the campuses,” says Prof Nicky Morgan, Acting Rector of the UFS.

 “We are committed to working together as institution in finding viable solutions to the plight of poor students at our university. The university management is also committed to participate in national initiatives to revise the manner in which universities are funded,” says Prof Morgan.

Information about the predicates and upcoming exam will be shared with students on the various communication platforms of the university on Friday 23 October 2015. Students who had to write tests or exams, but could not do so due to the protest action, will not be prejudiced.

 
Released by:
Lacea Loader (Director: Communication and Brand Management)
news@ufs.ac.za
+27(0)51 401 3422
+27(0)83 645 2454


Facebook message from UFS SRC (26 October 2015)

UFS welcomes Pres Jacob Zuma’s statement about 0% increase in tuition fees for 2016 (23 October 2015)

UFS postpones examinations to Monday 2 November 2015 (23 October 2015)

Letter to students from Prof Jonathan Jansen about student protest actions at the UFS (22 October 2015)

UFS obtains court interdict against protesting students - classes will resume on 22 October 2015 (21 October 2015)

UFS management closes down all three campuses on 21 October 2015 (20 October 2015)

UFS responds to concerns around high costs of higher education (Letter from Prof Jonathan Jansen -19 October 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