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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

Twee broers lewer intreerede
2004-06-10

‘n Unieke geleentheid sal homself môre, 9 Junie 2004, voordoen wanneer twee broers - proff Francois en Janse Tolmie - tydens dieselfde geleentheid hul intreeredes aan die Universiteit van die Vrystaat (UV) sal lewer.

Prof Francois Tolmie is verbonde aan die UV se Departement Nuwe Testament en die onderwerp van sy lesing is Die impak van die metodologie op die verstaan van die Nuwe Testament. Prof Janse Tolmie, sy jonger broer, is verbonde aan die UV se Departement Rekenaarwetenskap en Informatika en die onderwerp van sy lesing is Die rol van inligtingstegnologie in kennisbestuur.

Hoewel die studievelde vér verwyderd staan, klop die twee broers se missies wat betref die terugploeg van die verworwe vakkennis ten bate van die gemeenskap. Prof Francois Tolmie is nóú betrokke by dowes en Prof Janse Tolmie tap weer kunsmatige intelligensie ten bate van die mediese wetenskap en geestesgesondheid.

Prof Francois Tolmie verwerf die grade BA, BA Honneurs (Grieks), MA (Grieks), B Th en M Th almal cum laude aan die UV. In 1992 verwerf hy 'n D Th (Nuwe Testament) en in 2004 'n Ph D (Grieks) aan dieselfde universiteit. Na sy militêre diens as kapelaan in Walvisbaai aanvaar hy 'n beroep na die NG-gemeente Walvisbaai. Hy begin sy akademiese loopbaan op 1 April 1990 as senior lektor in die Departement Nuwe Testament en word in 1999 tot medeprofessor en in 2003 tot professor bevorder.

Sy navorsingspesialiteit is die Johannesevangelie en die Brief aan die Galasiërs. Hy is tesourier van die Nuwe Testamentiese Werksgemeenskap van Suid-Afrika, lid van die Society of Biblical Literature en die Studiorum Novi Testamenti Societas, redakteur van Acta Theologica en assistent-redakteur van Neotestamentica. Hy het reeds 34 artikels in geakkrediteerde tydskrifte gepubliseer, asook drie populêr-wetenskaplike boeke en talle bydraes in populêr-wetenskaplike boeke. Hy het twee akademiese boeke in die buiteland gepubliseer - onderskeidelik in Nederland en in die VSA. Later vanjaar verskyn 'n derde akademiese boek in Duitsland. Hy is ook een van die vertalers van die Afrikaanse Bybel vir Dowes.

Prof Janse Tolmie verwerf die grade B Sc, B Sc (Hons) en M Sc (Cum Laude) in Rekenaarwetenskap aan die UV.

Hy is vanaf 1989 betrokke by die UV en was ook ’n dosent aan die Militêre Akademie in Saldanhabaai in 1990/91 en het klas gegee by DePaul Universiteit in Chicago in 2002.

In 1992 is hy vir ses maande gesekondeer na ’n patologiese firma, Van Drimmelen en Vennote, in Johannesburg vir die ontwikkeling van kennisgebaseerde sagteware. Met hierdie projek word hy een van slegs ’n handjievol navorsers in die wêreld wat daarin kon slaag om ’n mediese kundigheidstelsel te ontwikkel wat werklik gebruik word.

Hy verwerf sy Ph D in 1994 en in 1994/95 doen hy navorsing aan die Besigheidskool van Carleton Universiteit in Ottawa, Kanada. Hy word in 1997 bevorder tot mede-professor en in 2003 tot volprofessor. Vanaf 2003 tree hy op as departementele voorsitter van die UV se Departement Rekenaarwetenskap en Informatika.

Hy het meer as 30 publikasies al die lig laat sien, insluitend verskeie internasionale kongresbydraes en artikels in geakkrediteerde joernale. Hy was ook vir 2 siklusse geëvalueer by die NRF. Sy portfolio sluit in die ontwikkeling van sagteware of prototipes vir groot maatskappye soos Van Drimmelen en Vennote en Bayer Diagnostics (VSA). Sy privaatbesigheid fokus op die ontwikkeling van nismarksagteware vir tersiêre instellings. Die sagteware word tans gebruik deur afdelings aan verskeie universiteite in Suid-Afrika.

Die geleentheid vind om 19:00 in die CR Swart-ouditorium op die kampus plaas.

MEDIAVERKLARING

Uitgereik deur: Lacea Loader
Mediaverteenwoordiger
Tel: (051) 401-2584
Sel: 083 645 2454
E-pos: loaderl.stg@mail.uovs.ac.za
 

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