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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

Power interruptions: Information for internal communication
2008-01-31

As part of the UFS’s commitment to address load shedding, the management would like to communicate the following:

The UFS mainly deals with the power interruptions by way of (a) the possible installation of equipment (e.g. generators) and (b) operational arrangements to ensure the functioning of the UFS in spite of power interruptions.

During the past week progress was made on both fronts. The information that follows resulted from a meeting of a task team of Physical Resources led by Mr Nico Janse van Rensburg, which took place on Monday 28 January (this task team naturally focuses on physical solutions) and a discussion by Exco on Wednesday 30 January 2008. Exco discussed the recommendations of the mentioned task team in respect of physical aspects, as well as the operational arrangements proposed by faculties.

Physical solutions

A Main Campus

1. New emergency power installations already approved:

Last week Exco gave its approval for the design and installation of emergency power equipment in all the large lecture-hall complexes to proceed immediately.

In all these cases

  • load surveys have been completed and a start has been made with the ordering of equipment and the process of appointing contractors. (Exco approved the adjustment of normal tender procedures in an attempt to expedite completion.)
  • generators with 20-30% more capacity than required for the current load are being ordered.
  • provision is being made for the connection of lights and at least one wall plug to the emergency power.
  • the expected construction time is 16 weeks (except in the case of the Flippie Groenewoud Building where it is 6 weeks).

The above-mentioned concerns lecture halls/ venues in the following buildings: Examination Centre, Flippie Groenewoud Building, Stabilis, Genmin and the Agriculture Building.

As far as the Agriculture Building is concerned, a larger generator (larger than required for lecture venues only) is being ordered in view of simultaneously providing essential research equipment (refrigerators, ovens, glasshouses) with emergency power within 16 weeks.

2. Investigation into the optimal utilisation of present emergency power installations

All the emergency power systems are being investigated on the basis of a list compiled in 2006 to determine whether excess capacity is available and whether it is possible to connect additional essential equipment or lights to it.

The electrical engineer warns as follows:
“Staff members must under no circumstances overload present emergency power points.

A typical example of this is a laboratory with 10 power points of which 2 points are emergency power outlets. Normally a fridge and freezer would, for example, be plugged into the two emergency power points, but now, with long load-shedding interruptions, a considerably larger number of appliances are being plugged into the power point by means of multi-sockets and extension cords. In the end the effect of such connections will accumulate at the emergency generator, which will then create a greater danger of it being overloaded and tripping, in other words, no emergency power will then be available.”

3. Requests and needs addressed directly to Physical Resources or reported to Exco via the line managers.

All the physical needs and requests addressed directly to Physical Resources or submitted to Exco via the line managers are being listed, classified and considered technically in view of their being discussed by the task team on Monday 11 February.
The information will (a) lead to recommendations to Exco regarding possible additional urgent emergency power installations, and (b) be used in the comprehensive investigation into the UFS’s preparedness for and management of long power interruptions.

Requests that can easily be complied with immediately and that fit into the general strategy will indeed be dealt with as soon as possible.

4. Purchase of loose-standing equipment: light, small, loose-standing generators, UPSs as solutions to/ aids during power interruptions

Exco approved that

a) faculties and support services accept responsibility themselves for the funding and purchase of loose equipment such as, for example battery lights, should they regard these as essential.
b) UPSs (uninterruptible power supplies) that faculties and support services wish to purchase to combat the detrimental effect of unexpected power interruptions on computer equipment) can (as at present) be purchased from own funds via Computer Services.
c) UPSs (uninterruptible power supplies) that faculties and support services wish to purchase to combat the detrimental effect of unexpected power interruptions on other types of equipment can normally be purchased from own funds with the consent of the line manager concerned.
Note: Please just make sure of the appropriateness of the equipment for a specific situation: it is not a power supply that can bridge a two-hour power interruption.)
d) small, loose-standing generators can be purchased from own funds via Physical Resources and installed under their supervision.
e) laptop computers can , where necessary, be purchased from own budgets. The availability of second-hand laptop computers must be taken into account.

B Vista

No major problems have been reported to date. The situation is being monitored and will be managed according to need. The same guidelines that apply to the Main Campus will naturally also apply to the Vista Campus.

C Qwaqwa

The situation is receiving attentions and solutions have already been found for most problems.

D General

1. All-inclusive project
A comprehensive investigation into the UFS’s preparedness for and management of long power interruptions will be launched as soon as possible. Available capacity will be utilised first to alleviate the immediate need. The needs assessment to which all faculties and support services have already contributed is already an important building block of the larger project.

2. Building and construction projects currently in the planning and implementation phase
The need for emergency power for projects such as the new Computer Laboratory is being investigated proactively and will be addressed in a suitable manner.

3. Liaison with Centlec
Attempts at direct and continuous liaison are continuing in an attempt to accommodate the unique needs of the UFS.

4. HESA meeting and liaison with other universities
A representative of the UFS will attend a meeting of all higher education institutions on 11 February. The meeting is being arranged by HESA (Higher Education South Africa) to discuss the implications for the sector, the management of risks and the sector’s response to government.

5. Internal communication
It is the intention to communicate internally after every meeting of the task team, which will take place on Mondays. Strategic Communication will assist in this regard.


 

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