Who is the South African National Control Laboratory for Biological Products?

The Faculty of Health Sciences boasts several units of national importance, including the South African National Control Laboratory for Biological Products (SANCLBP). The primary function of the SANCLBP is to perform all vaccine lot release related activities as stipulated in the service level agreement between the South African Health Products Regulatory Authority (SAHPRA) and the UFS.

The SANCLBP is a South African National Accreditation System (SANAS) ISO/IEC 17025:2017 accredited pharmaceutical testing laboratory which performs quality control tests on vaccines for human use in South Africa (The SANAS Certificate containing the scope of accreditation is available on the SANAS website or from the laboratory). The SANCLBP is also a World Health Organisation (WHO) contracted laboratory for testing prequalified vaccines and a full member of the WHO National Control Laboratory Network for Biologicals (WHO – NNB) and is committed to the current best international practice for the lot release testing of vaccines. 

History

The SANCLBP was established in 1998 at the University of the Free State through a tender from the National Department of Health (DoH). The mission of the SANCLBP is to ensure that all vaccines for human use meet the quality standard as registered by SAHPRA before it is released to the market.

Function

Biological medicines such as vaccines are complex products. They differ from pharmaceuticals in that they are produced in a biological manufacturing process. The potential variability intrinsic to these manufacturing processes and, therefore the biological product, requires that they are subjected to extensive quality control testing.

Vaccines are used in healthy populations and thus, safe and effective vaccines are essential public health tools that 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.

Vaccine lot release activities, as conducted by the SANCLBP, are part of the regulatory process of vaccines and involve the independent evaluation of each vaccine lot before it is released onto market. All vaccines registered by SAHPRA or authorised under section 21 are subject to lot release by SAHPRA. Vaccine lots will be released for public use only if they conform to the required specifications. 

 The SANCLBP has modern facilities that include virology, cell culture, microbiology, biophysical chemistry, immunochemistry and molecular biology.

• The SANCLBP maintains the highest standards by complying with the ISO/IEC 17025:2017, WHO Guidelines, and SAHPRA GMP standards.
• The SANCLBP strives to collaborate with other African countries by making its laboratories available for testing when required and providing training opportunities.
• The SANCLBP maintains international collaboration with other control laboratories in Europe, the UK, and the WHO.