Latest News Archive

Please select Category, Year, and then Month to display items
Years
2017 2018 2019 2020
Previous Archive
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

Wildlife researcher in ground-breaking global research on giraffes
2017-10-20

Description: Giraffe read more Tags: giraffe, conservation, Dr Francois Deacon, Last of the Long Necks, Catching Giants 

Dr Deacon from the Department of Animal, Wildlife and Grassland
Sciences at the University of the Free State (UFS),
lead a multispecialist research group to catch
and collar giraffe to collect data that will
contribute to the conservation of these animals.
Photo: Prof Nico Smith


Capturing 51 giraffes without any injuries or mortalities to collect data that will contribute to the conservation of these animals is not for everyone. Capturing a giraffe with minimum risk to the animal and the people involved, requires extraordinary skill, planning, and teamwork. “This exercise is a dangerous task, since a well-placed kick from these large and extremely powerful animals can cause serious injuries. Early in October was the first time that giraffes were captured on such a large scale,” said wildlife researcher Dr Francois Deacon.
 
Dr Deacon from the Department of Animal, Wildlife and Grassland Sciences at the University of the Free State (UFS), led a multispecialist research group of over 30 people from 10 different countries to collect information about these little-known animals.

UFS first to collar giraffe
Taking a global approach, the team responsible for this intricate process consisted of wildlife biologists, conservationists, interdisciplinary scientists and five specialist veterinarians who are experienced in catching and working with wild animals. Specialised drugs sponsored by Dr Kobus Raath from Wildlife Pharmaceuticals, tested for the first time and administered with a dart gun were used to tranquillise the giraffe, which then allowed for the GPS collars to be fitted.  These collars, sponsored by Africa Wildlife Tracking, enable the researchers to record the location of individual giraffe for up to two years, give 24/7 readings, irrespective of weather conditions. In this cost-effective manner, data can be gathered on climatic factors, giraffe communication, social behaviour, home ranges, seasonal movements, human and giraffe interaction zones, as well as migration routes and the duration of the migration process. The collars will effectively be used to locate individuals to collect faecal samples for hormonal cycles, stress hormones, nutrient deficiencies based on diet and also internal parasites. 

“This knowledge we gain is the key to all keys in saving this iconic animal from becoming extinct,” said Dr Deacon.

Six years ago, during a pilot study, Dr Deacon was the first researcher to fit giraffes with a GPS collar. Collaring is less invasive and allows researchers to collect detailed samples. Not only was extensive knowledge and experience gained during the process, but he also initiated interest from the filmmaker and conservationist, Ashley Scott Davison, executive producer of Iniosante Inc. 

Getting to tell the story

Davison, who was doing research for a film on giraffe learnt about the silent extinction of the species. In a great number of countries giraffe numbers have been declining by as much as 40% over only a few years since 2000. Today West Africa has between 400 to 600 giraffe left while four out of five giraffes were lost in East Africa since 2000. This is a considerable decline in numbers and poses a real threat to the survival of the species in the longer term. At the end of 2016, the giraffe was classified as vulnerable on the International Union for Conservation of Nature Red Data list.

According to Davison, children in school learn about the destruction caused by ivory poaching and habitat loss. But in Africa today, there are six times as many elephants as there are giraffes. 

In the process to find out more about this majestic species Davison learnt of Dr Deacon’s work. After being introduced to and spending time with Dr Deacon, Davison not only describes the UFS as the leader in the conservation of giraffes but he returned to the university, three times to help build a dedicated research team to address unanswered research questions within various disciplines.

Flowing from the affiliation with the UFS is Iniosante’s award-winning production of a documentary, “Last of the Longnecks”. The film has received several awards, including official selection at the 2017 Global Peace Film Festival, the Wildlife Conservation Film Festival and the Environmental Film Festival in the US capital. 

The film team accompanied the multispecialist research team last week to gather footage for a follow-up documentary, “Catching Giants”. This film is expected to air in middle 2018.

 Video clip of the event: https://www.dropbox.com/s/d3kv9we690bwwto/giraffe_UFS_revision-01a.mp4?dl=0

Video clip of the event: RooistoelTV

Former articles on this topic:

18 Nov 2016: http://www.ufs.ac.za/templates/news-archive-item?news=7964 
23 August 2016: http://www.ufs.ac.za/templates/news-archive-item?news=7856 
9 March 2016:Giraffe research broadcast on National Geographic channel
18 Sept 2015 Researchers reach out across continents in giraffe research
29 May 2015: Researchers international leaders in satellite tracking in the wildlife environment

 

 

 

 

 

We use cookies to make interactions with our websites and services easy and meaningful. To better understand how they are used, read more about the UFS cookie policy. By continuing to use this site you are giving us your consent to do this.

Accept