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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

Walk to Cape Town closes on high note
2014-06-03

Photo Gallery of arrival in Cape Town
Dagbreek interview (kykNet) (YouTube)
Thank you from all UFS students (YouTube)

It was a gruelling road totalling a distance of 1 038 km, but the UFS #NSHstride team completed the challenge of walking all the way to Cape Town.

On Thursday 1 May 2014, Adéle van Aswegen and Ntokozo Nkabinde, both from the UFS, took on the road to Cape Town on foot in order to highlight the problem of food insecurity among students at the UFS.

Two kind-hearted Bloemfontein residents, Nico Piedt and Ronél Warner, tackled the journey together with them, not only to draw the country’s attention to food insecurity, but also to raise money to address the problem.

The hike, known as the No Student Hungry 1000/33 stride (or #NSHstride), came to an end at the St George’s Cathedral in Cape Town on Tuesday 3 June 2014.

About R500 000 were raised before, during and after the foursome’s hike.

The NSH bursary, established in 2011 by Prof Jonathan Jansen, the Vice-Chancellor and Rector of the UFS, and Rudi Buys, Dean of Student Affairs, aims to put food insecurity among students at the UFS under the spotlight.

Rudi Buys, Dean of Student Affairs, says: “We are completely inspired by the victory of a 1 000 km with one step at a time – as it reminds us of the courage of our students who beat hunger one day at a time.”

“The stride team challenges us to change our world for the better every day. We hope to continue their victory for students by challenging all universities to join the struggle for food security and will call a colloquium in this regard in October.”

These boots are made for walking ... to Cape Town (Article of 02 May 2014)
“Aren’t auntie and them hungry yet?” Country folk worried about NSH hikers (15 May 2014)
UFS hikers to Cape Town reflect on their journey (Article of 26 May 2014)

Daily updates:
(You can also follow us on @UFSweb for daily tweets)

Day 33: 2 June 2014
13:40
20 km
Sunset Beach, Cape Town

Day 32: 1 June 2014
16:05
26 km
Mervyn and Sanet Wessels, Belville

Day 31: 31 May 2014
16:31
39.6 km
Rhonell and Gavin Julain, Paarl

Day 30: 30 May 2014
14:00
16 km
Monte Rosa, Rawsonville

Day 29: 29 May 2014
13:16
31 km
The Habit, Worcester

Day 28: 28 May 2014
11:00
22.4 km
Monte Roza, De doorns

Day 27: 27 May 2014
17:00
21.1 km
Karoo Hotel

Day 26: 26 May 2014
18:27
43.3 km
Tows river

Day 25: 25 May 2014
12:18
Lord Milner Hotel, Matjiesfontein

Day 24: 24 May 2014
16:30
42 km
Laingsburg Country Lodge

Day 23: 23 May 2014
17:32
41.8 km
Vergenoeg

Day 22: 22 May 2014
16:42
43 km
Assendelft Lodge and Bush Camp, Prins Albert

Day 21: 21 May 2014
15:09
42 km
Leeu Gamka Hotel

Day 20: 20 May 2014
13:39
20 km
Alida, Springfontein

Day 19: 19 May 2014
12:31
27.6 km
Teri Moja Game Lodge

Day 18: 18 May 2014
First rest day
Nagenoeg Guesthouse, Beaufort West

Day 17: 17 May 2014
19:30
62.3 km
Nagenoeg Guesthouse, Beaufort West

Day 16: 16 May 2014
13:00
14 km
Taaibochfontein

Day 15: 15 May 2014
16:03
32 km
Travalia, Three Sisters

Day 14: 14 May 2014
18:33
43 km
Joalani Guest Farm

Day 13: 13 May 2014
17:30
33 km
Die Rondawels

Day 12: 12 May 2014
16:49
40 km
Aandrus B&B in Richmond

Day 11: 11 May 2014
39 km
Wortelfontein (Magdel and Christiaan)

Day 10: 10 May 2014
15:44
34 km
Hanover Lodge

Day 9: 09 May 2014
40.8 km
Camping between Colesberg and Hanover

Day 8: 08 May 2014
15:25
33.7 km
Colesberg, The Lighthouse Guesthouse

Day 7: 07 May 2014
15:08
23 km
Orange River Lodge

Day 6: 06 May 2014
15:57
51.06 km
Gariep Forever Resort

Day 5: 05 May 2014
12:18
28 km
Rondefontein

Day 4: 04 May 2014
15:27
35 km
Trompsburg: Fox Den

Day 3: 03 May 2014
17:30
46.74 km
Edenburg Country Lodge (Hotel)

Day 2: 02 May 2014
11:44 am
15.3 km
Tom's Place

Day 1: 01 May 2014
32 km
Leeuwberg

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