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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 takes steps to address power shedding
2008-01-31

The problem of power shedding was urgently discussed by the Executive Committee of the Executive Management (Exco) during its meeting yesterday.

A report was presented by Ms Edma Pelzer, Director: Physical Resources and Special Projects, and a consulting electrical engineer about possible short, medium and long term solutions for the UFS.

This includes (a) the possible installation of equipment (eg. power generators) and (b) operating procedures to ensure the UFS’s functionality despite power shedding.

We are also in contact with Centlec to bring about the best possible arrangements for the UFS regarding the power shedding. It is possible that refined power shedding schedules will be implemented within a few weeks or a month to ensure that there is minimal disruptions at the UFS (especially during evening lectures).

In the long term it is unaffordable to generate power for the whole campus to meet everyone’s electricity needs. Only critical points will be supplied with emergency power generators.

Emergency power generation for certain critical points have already been provided for (eg. the Callie Human Centre, the evacuation of large halls, computer services, critical long term research projects, etc.). We have been doing surveys since 2006 to determine the UFS’s preparedness for “normal” power failures. The extent of the current situation has, however, taken the whole country by surprise.

Certain urgent steps were decided on yesterday. A decision was made to immediately design emergency power systems and supply it to the new examination centre and large lecture halls such as the Stabilis, Flippie Groenewoud, Agriculture building, and possibly the West Block. The delivery and installation of these systems will, however, take from three to six months.

The UFS will have to manage despite the power shedding, even after the emergency power systems have been installed and we will not be able to function as normal. Every division must devise operating procedures to deal with the power shedding without jeopardising the quality of core functions.

Bloemfontein is luckier than many other cities because Centlec is able (so far) to keep to the published schedule to a large extent.

Plans are also being made to keep staff and students continuously informed via the UFS web site about expected power shedding schedules and risks of power shedding in the course of a day.

Exco requests every faculty and support service to think about suitable operational solutions for managing their work and meetings during a power shedding.

Every line head has instructions to urgently determine the situation and needs in his or her division and indicate what practical arrangements can and must be made to schedule work around the power shedding. Every line head must provide Exco with a status report within a week.

In this way critical areas in terms of core functions and high quality service delivery will be determined and receive attention. Security systems and the safety of staff and students will also receive specific attention - this includes the residences.

In the mean time the Department of Physical Resources will carry on with a wide-ranging investigation into the extent of needs and plans and will compile a budget for the solution thereof.

Prof. Teuns Verschoor, Vice-Rector: Academic Operations, and the deans had a meeting yesterday to discuss problems and possible solutions around the power shedding in eg. computer rooms, during evening lectures, and practical classes.

Options may include eg. alternative time slots (eg. weekends) or alternative halls (eg. at the Vista Campus) for evening lectures which are affected by power shedding, or adjusted teaching methods.

Staff is requested not to install their own power generators under any circumstances. It can be very dangerous when such apparatus are linked to a building’s electrical system. The safety of staff and students and the risks of fire or injuries must also be the highest priority under all circumstances.

The Department of Physical Resources is also in the process of investigating options such as smaller power generators or ‘UPS’ apparatus as part of a broader evaluation of needs and potential solutions.

Exco wants to ensure all staff and students that this matter is receiving urgent attention and will keep on receiving it.

If there are any practical solutions about dealing with the power shedding (such as alternative ways of working) you are invited to send an e-mail to: lightsout@ufs.ac.za  

 

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