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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 celebrates Kovsie Week
2009-08-21

The University of the Free State (UFS) will be celebrating Kovsie Week from 31 August to 4 September 2009. The week affords friends, colleagues and former colleagues of the UFS the opportunity to enjoy one another’s company and to experience what the university offers.

The programme is as follows:

On Monday, 31 August 2009, a star-gazing programme and lecture entitled “400 Years of Astronomy after Galileo” are presented by Prof. Matie Hoffman at the Boyden Observatory at 17:30 for 18:00. Attendance is free and bus transport will be available from the UFS Main Campus for the first 70 guests that respond. Reserved parking has been arranged with a security guard to look after the cars that are left on the campus.

On Tuesday, 1 September 2009, guests can attend the production by Pieter Venter entitled “Impi” for free in the Wynand Mouton Theatre at 14:30 for 15:00.

On Wednesday, 2 September 2009, an enjoyable morning in the company of Mr Derek de Bruyn from the National Museum is presented at the Centenary Complex of the UFS at 09:30 for 10:00. He will talk about the social life of Bloemfontein during the early 1900s and guests will be entertained by the Boere Orkes of Grey College Primary School under the direction of Santjie Louw. Attendance of this event is free.

On Thursday, 3 September 2009, at 19:00 for 19:30, a candle-light, sherry and soup evening with romantic piano music is presented at the UFS Centenary Complex by Prof. Nicol Viljoen from the UFS’s Department of Music. The programme includes, amongst others, 10 Lieder ohne worte (Felix Mendelssohn), as well as Ballade No. 1 (Fryderyk Chopin). Attendance of this event is also free.

The week will end with the Kovsie-Alumni Award Gala Dinner that will take place in the UFS Centenary Complex on Friday, 4 September 2009, at 18:30 for 19:00.
The cost per person for the dinner is R120. The Kovsie of the Year Award for alumni, the Cum Laude Award, and the Alumni Award for Exceptional Service at the UFS will be awarded at this occasion.

Transport can be arranged to all the functions and parking will be available as close as possible to the venue where the functions take place. Persons interested to attend any of the functions can contact Annanda Calitz at 051 401 3382 or ficka.stg@ufs.ac.za, or Ms Kathy Verwey at 051 401 9343 or verweyke.stg@ufs.ac.za.

Media Release
Issued by: Lacea Loader
Deputy Director: Media Liaison
Tel: 051 401 2584
Cell: 083 645 2454
E-mail: loaderl.stg@ufs.ac.za  
21 August 2009

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