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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 shortage: Measures to be implemented immediately
2008-01-31

1. In order to avoid the further implementation of power sharing, electricity companies countrywide are requiring, in addition to measures announced for domestic consumers, that major power consumers save a certain percentage of power.

2. Die UFS is one of the 100 largest clients of Centlec, the local electricity distribution company. During a meeting last Thursday evening with the 100 largest clients, it was indicated that the UFS had to deliver a saving of 10%. The details are as follows:

  • Provision is made to a certain extent for an increase in electricity consumption. The calculation is done as follows: maximum consumption for 2007+6%-10%.
  • This entails a saving during peak times, as well as a saving regarding the total number of units consumed.
  • The saving is calculated on a monthly basis.
  • Saving measures must be implemented immediately (from 7 March). If electricity-saving goals are not attained, power sharing will be resumed from 10 March.

3. The UFS has been controlling its peak demand by means of an energy control system for many years. The geysers of residences and certain central air-conditioning systems were linked to the control system in order to shift energy consumption to non-peak times.

4. In order to attain the goal of 10%, it is necessary to implement further energy control systems and additional measures – which requires time and money. Attention will have to be given, inter alia, to the following:

  • The 1000+ portable air-conditioning units on the campus (huge power guzzlers) must be connected to energy control appliances and systems.
  • All the filament bulbs must be replaced.

7. The UFS will be conducting high-level talks with Centlec later this week with a view to:

  • conveying the unique needs of the UFS in detail;
  • stating the impact of building and refurbishing projects that are currently in the implementation and planning phases;
  • requesting understanding for the fact that the UFS does not have the capacity to immediately deliver the 10% saving.
     

It is evident from discussions thus far that Centlec is sympathetic and wants to help, but also that immediate action and co-operation are expected from the UFS. During the meeting, the UFS must also report back on steps already taken (since 7 March) in this regard.

8. The installation of the emergency power units for the large lecture-hall complexes and a few other critical areas, which has already been approved, is continuing. About R3m is being spent on this. Additional emergency power needs reported to Physical Resources via line managers are currently being investigated with a view to obtaining a cost estimate and subsequently determining priorities in consultation with line managers.

It is recommended that:

a) All line managers, staff members and students be requested to give their full co-operation with regard to saving electricity in every possible way, and that current operational arrangements be amended if possible with a view to promoting power saving. 

Staff, students and other users of campus facilities be requested to see to it that lights and air conditioning (individual units) in unused areas are switched off.

b) The following measures drawn up in co-operation with electrical engineers come into effect immediately:

Arrangements to be made by Physical Resources staff:
(Additional capacity to be able to complete everything within a reasonable period of time will have to be found and funded. This aspect will be taken up with the line managers concerned):

  • The geysers of all office buildings will be switched off at the distribution board. Staff are requested to use a kettle for washing dishes, and are warned not to switch appliances on again themselves.
  • In all office buildings where 12V and 15W downlighters and uplighters remain switched on for decorative purposes and do not serve as primary illumination, the light switches will be disconnected.
  • Lighting in cloakrooms will be checked, and illumination levels will be reduced if possible.
  • All light armatures must be replaced by CFL types.
  • All lights on the grounds will be checked to ensure minimum power consumption.
  • The upper limit of all central cooling systems currently regulated via the energy control system must be set to 24 degrees.

Arrangements to be made by Kovsie Sport:

  • Sport activities requiring sports field illumination must be scheduled after 20:00 in the evening (the lights may not be on between 18:00 and 20:00.)
  • Sports field illumination must be managed so that such lights are not switched on unnecessarily.
     

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