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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

You touch a woman, you strike a rock
2004-11-02

Prof. Engela Pretorius van die Departement Sosiologie in die Fakulteit Geesteswetenskappe by die Universiteit van die Vrystaat het die kwessie omtrent feminisme aangespreek tydens haar intreerede met die onderwerp, You touch a woman, you strike a rock: Feminism(s) and emancipation in South Africa .

Prof. Pretorius het gesê: “Die geskiedenis van feminisme oor die algemeen kan in drie fases verdeel word, waarna verwys word as golwe. Eerste-golf-feminisme (19de eeu) het die fokus geplaas op die beskerming van vroueregte in die openbare terrein, spesifiek die reg om te stem, die reg tot onderrig en die reg om middelklas beroepe en professies te betreë.

Vroeë tweede-golf-feminisme word onthou vir hoe dit moederskap geteoretiseer het as synde ‘n onderdrukkende instelling. Slagspreuke van die 1970s was die persoonlike is polities en susterskap is magtig. Prof. Pretorius sê beide slagspreuke bevestig die idee dat vroue universeel onderdruk en uitgebuit word en slegs deur erkenning van dié situasie kan vroue die strukture wat hul onderdruk verander.

‘n Belangrike aspek van die derde golf van die feminisme-teorie is post-moderne feminisme wat diversiteit en verskille onderstreep. Die poging van hierdie feministe is afgestem op alle vorme van onderdrukking. Vroue van kleur het ook hul ontevredenheid uitgespreek gedurende die derde-golf-feminisme. Die feminisme van vroue van kleur word gekenmerk deur verskeie kwessies en talryke intellektuele standpuntinnames wat neerslaga vind in verskillende terme, soos Afrika feminisme of ‘womanism, sê prof. Pretorius.

Afrika-feminisme dui protes aan teen die wit/westerse geskiedenis en die wit/westerse dominansie binne feminisme. Afrika-vroue het besef dat hul onderdrukking verskillend is van dié van wit vroue en daarom is ‘n ander proses van bevryding nodig. Die Westerse feministiese praktyk om swart vroue by die bestaande feministiese ontologie te voeg, is nie voldoende nie omdat hul unieke ondervindings van slawerny, kolonialisme, onderdrukking deur mans en armoede nie uitgedruk word nie.

‘Womanism’ het tot stand gekom as gevolg van ‘n eksplisiete rassekritiek teen feminisme. Dit is ten gunste van die positiewe uitbeelding van swart mense. Dit word gekenmerk deur kulturele kontekstualisasie, die sentraliteit van die gesin en die belangrikheid daarvan om mans in te sluit.

Die geskiedenis van vroue in Suid-Afrika is verwant aan hul geskiedenis van onderdrukking as gevolg van patriargie. Vroue van verskillende rasse, kulture en klasse het patriargie op verskillende wyses in en variërende mate van erns ervaar. Onder voor-koloniale patriargie het vroue min sê gehad oor huwelikskeuses omdat mans dié besluite gedomineer het.

Die Nederlandse en Britse patriargale erfenis het neerslag gevind in die ideologie van die volksmoeder. Onderwyl dit veral manlike skrywers was wat die beeld van die vrou as versorger en tuisteskepper bevorder het, het vroue self ook hieraan ‘n aandeel gehad, sodat die volksmoeder volwaardig deel geword het van die Afrikaner nasionalistiese mitologie. Alhoewel middel- en werkersklas vroue met dié beeld geïdentifiseer het, het nie alle Afrikaanse vroue die ideologie aanvaar nie.

Onder die Victoriaanse erfenis was Britse vroue beperk to die private eerder as die openbare lewe. Die skeefgetrekte onderrigsisteem wat vroue in huishoudelike loopbane gekanaliseer het, die mag van mans oor hul vroue se eiendom en ‘n tekort aan toegang tot mag en geld het verseker dat vroue by die huis gebly het.

Wit Engelssprekende-vroue het die grootste geleentheid gehad om patriargie uit te daag vanweë hul toegang tot onderwys en die blootstelling aan liberale waardes, sê prof. Pretorius. Liberale vroue soos Helen Joseph en Helen Suzman het ‘n belangrike rol gespeel om in 1930 stemreg vir wit vroue in Suid-Afrika te verseker en het voortgegaan om ‘n rol te speel in die bevryding van swart vroue gedurende die vryheidstryd.

Die feminisme wat onder swart vroue ontwikkel het, was ‘n erkenning van die gemeenskaplike stryd met swart mans om die verwydering van die juk van eksterne onderdrukking en eksploitasie. Swart vroue in aktiewe en onafhanlike politiese rolle het tegelykertyd mans se aannames omtrent hul meerderwaardigheid asook die rassewette van die staat uitgedaag. Daarom kan ons sê dat die feminisme wat hier ontwikkel het, te voorskyn gekom het as gevolg van vroue se betrokkenheid by en toewyding tot nasionale bevryding, sê prof. Pretorius.

Institusionalisering is nie herlei tot magsvoordele nie, want gelykheid is nie in beleidsprogramme geïnkorporeer nie. Die hervestiging van sleutel aktiviste van die vrouebeweging in die regering het die stryd om genderbillikheid verander na ‘n projek wat deur die regering gelei word, sê prof. Pretorius. Ongelukkig word terreine van verandering buite die grense van die regering verwaarloos. Dit kan slegs aangespreek word deur ‘n aktiewe en feministiese stem in die burgerlike samelewing.

“Dit is my oortuiging dat formele instellings vir vroue binne die staat oor die lang termyn slegs effektief kan wees indien daar ‘n effektiewe feministiese vroue-beweging buite die staat in stand gehou word wat die grondslag waarop sosiale beleid gevorm word, kan uitdaag en bevraagteken. Daarom, A luta continua (die stryd duur voort),” sê prof. Pretorius.

Mediaverklaring
Uitgereik deur: Lacea Loader
Mediaverteenwoordiger
Tel: (051) 401-2584
Sel: 083 645 2454
E-pos: loaderl.stg@mail.uovs.ac.za
2 November 2004

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