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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

Reaction by the Rector of the UFS after a meeting with student leaders
2008-02-25

Reaction by the Rector and Vice-Chancellor of the UFS, Prof. Frederick Fourie, on the agreement reached at a meeting with student leaders held on Friday, 22 February 2008

Note: This is meant to be used together with the full joint statement that was issued by the UFS management and student leaders on 22 February 2008.

The memorandum of the primes of the University of the Free State’s (UFS) residences was handed to top management on Wednesday, 20 February 2008. In the memorandum they asked for a meeting with the UFS management by Friday, 22 February 2008. Such a meeting was arranged and took place.

The UFS top management, all the residence primes as well as the house committee member for first years, the executive of the Main Campus Student Representative Council (SRC) and residence heads were present.

In contrast to what is suggested in the Volksblad report of Saturday, the discussion went off very well. There was no consternation or shouting or “emotions that ran high”. It was a civilised, decent meeting as it should be at a good university. Of course, now and again individuals spoke out strongly and very enthusiastically, but it was all decent and orderly. The contribution of the primes was insightful and well formulated.

Because the top management and I wanted to listen very carefully what the problems and frustrations were, we spent nearly five hours in the meeting. The issues in the memorandum were discussed one by one. In some cases I could take a decision immediately and finalise the matter, in other cases, the management provided information that could largely finalise a matter. A number of other matters must be investigated further.

The management undertook to respond comprehensively and in writing to all the issues raised in the memorandum by Monday, 25 February 2008. This will be handed to the primes but will not be handed to the media beforehand.
It is obvious that there are matters at the university that can be better managed and that there are problems with communication within the Student Affairs division. A major change such as the new policy on diversity places huge demands on management and the administration, and problems were to be expected. However, we understand the frustration of the students in residences.

On the other hand, students don’t always make matters easier. The strong opposition of white student leaders last year, and their unwillingness to co-operate in preparation for 2008 is well known. This year it is going better. But often student leaders take positions that are very inflexible. They also see no room for adapting old habits and simply want their own way. Their contributions are then full of statements such as “It cannot be done”. This delays measures such as the full implementation of expert interpreting services, which, for the management, is a very important measure (and which is functioning very well in certain residences). Communication from student leaders to management is also not always what it should be.

At the end of the meeting student leaders and management reached an important agreement and issued a joint statement in which they committed themselves to the integration process and to good co-operation and communication. This was an important step which is a sign of rebuilding trust. Naturally everyone will still have to work hard to build on this and to strengthen mutual trust.

The course and outcome of Friday’s discussions, as requested by the student leaders, show that issues can be addressed and resolved by means of us talking to one another. This is why it is so sad that primes and house committee members went on strike on Wednesday already and stayed in tents in front of the Main Building – leaving their residences without its leadership. This created an opening for what appears to have been well planned and co-ordinated acts of vandalism by inhabitants of residences on the campus on Wednesday.

Such vandalism is unacceptable and no one can justify it.

Fortunately, order could be restored quickly during the night and all academic activities could resume without any disruption on Thursday and Friday.

FCvN Fourie

Media Release
Issued by: Lacea Loader
Assistant Director: Media Liaison
Tel: 051 401 2584
Cell: 083 645 2454
E-mail: loaderl.stg@ufs.ac.za   
24 February 2008

 

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