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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

UFS presents sport concussion programme for schools
2008-11-14

The Sports Medicine Clinic at the University of the Free State (UFS) will present a sports concussion programme for schools in the Free State.

“The Pharos Schools Concussion Programme makes the latest methods and technology in concussion management available to learners who play contact sport,” says Dr Louis Holtzhausen, Programme Director of Sports Medicine at the UFS.

The great risk of concussion is that there is an uncertainty about when a player can return to a sport with safety and with the minimum complications in the brain. This programme fills that gap to a large extent.

“By using this programme, no player who suffers concussion will return to play before it is medically safe to do so. The programme also educates players, parents, coaches and the medical fraternity on how to manage sports concussion,” says Dr Holtzhausen.

The programme has been designed for hockey, soccer, cricket, rugby and other contact and collision sports.

SA Rugby has used the programme for professional players for the last five years and advocates that all school rugby players should participate in the programme.

Several sports teams from schools in and around Bloemfontein as well as the University’s Shimla and Irawa rugby teams have already been tested. This will provide invaluable information in the management of possible head injuries.

“We can now give definite guidelines to players and coaches regarding the safe return of players to teams after such an injury. It takes a lot of the guesswork out of the management of concussion and provides peace of mind to coaches, parents and players regarding serious injuries,” says Dr Holtzhausen.

By enrolling in the concussion programme, learners and their parents are ensured of among others:

A baseline computer brain-function test before the start of the season.
Information on how to recognise and treat concussion, including a fieldside information card for the player’s team.
A free consultation and neurological examination by a sports physician after any suspected concussion.
As many brain-function tests and sports-physician consultations as necessary after any concussion, until complete recovery.
Referral to a network of specialists if necessary.

The Pharos Programme uses a cognitive function evaluation called Cogsport. This is a neurophysiological test that measures brain function before the season starts. In this way, a baseline standard is established and, should concussion occur during the season, the extent of it can be measured according to the baseline and rehabilitation.

“Once we have the baseline values, the concussed player’s return to those levels must be monitored. He/she can return to light exercise in the meantime and semi- and full-contact can be introduced at appropriate times,” says Dr Holtzhausen.

The cost of enrolment is R200 per learner, regardless of the number of concussions suffered or sports physician consultations received. “By enrolling in this programme, parents will ensure that their child has the best chance of avoiding the potentially serious consequences of concussion, including learning disabilities, recurrent concussions, epileptic fits and even death,” says Dr Holtzhausen.

More information on the programme can be obtained from Ms Arina Otto at 051 401 2530.

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  
14 November 2008
 

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