UFS National Control Laboratory for Biological Products

University of the Free State UFS National Control Laboratory for Biological Products

UFS National Control Laboratory for Biological Products – check below:

Who is the National Control Laboratory?

The Faculty of Health Sciences boasts a number of units of national importance, including the National Control Laboratory (NCL), which is the vaccine testing laboratory of the Medicines Control Council of the National Department of Health. It is the only laboratory of its kind in Africa. The NCL is a SANAS accredited quality control laboratory which tests and releases all vaccines for human use in South Africa. We are one of twelve laboratories worldwide who are contracted to do testing for the World Health Organisation and we are part of the Global WHO-NCL Network for Biologicals.

History

The NCL was established in 1998 at the University of the Free State through a tender from the National Department of Health. The mission of the NCL is to ensure that all vaccines for human use in the country are safe, efficacious and of a high standard.

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Function

Biological products are different to conventional pharmaceutical products in that the raw materials used in the manufacturing of the vaccine have inherent variability. Vaccines are biological medicines and are some of the most complex pharmaceuticals available today. They are used in healthy populations; therefore, safe and effective vaccines as essential public health tools are strictly regulated internationally. This ensures that the vaccines are manufactured according to the required prerequisites and specifications of registration before they can be placed on the market. The NCL is part of this regulatory system. It is the NCL’s responsibility to perform quality control testing, as well as an independent review of the manufacturing and quality control data of all human vaccine lots used in South Africa. Vaccine lots will be released for public use only if they conform to all the required specifications.

The NCL has modern facilities which include virology, cell culture, microbiology, serology and immunochemistry, quantitative PCR and ion chromatography (HPAEC-PAD).

  • The NCL maintains the highest standards by complying with the ISO17025:2005, World Health Organisation Guidelines, and the South African National Regulatory Authority.
  • The NCL strives to collaborate with other countries in Africa by making its laboratories available for testing when required and by providing training opportunities.
  • The NCL maintains international collaboration with other control laboratories in Europe and the UK, and the World Health Organisation.
  • The NCL is very aware of the fact that vaccines are given to healthy babies, infants and people, and regards it as its mission to ensure that only vaccines which conform to international quality standards are available in South Africa.

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