SAHPRA collaborates with Germany’s BloodTrain programme

Pretoria, 10 October 2022 – The South African Health Products Regulatory Authority (SAHPRA) hosted representatives from Germany’s Paul Ehrlich Institut’s (PEI) BloodTrain programme to discuss activities in strengthening blood and blood product regulations in Africa.

SAHPRA enters this collaboration after participating in the PEI and African Union Development Agency (AU-NEPAD) blood regulatory system benchmarking.

BloodTrain carried out a face-to-face training workshop in Cape Town on quality management and inspection of blood establishments in collaboration with the European Blood Inspections System (EuBIS) and the African Society for Blood Transfusion (AfSBT). SAHPRA has also invited SANAS and two blood transfusion services to the training workshop, namely, the South Africa National Blood Services and the Western Cape Blood Service.

BloodTrain conduct all their activities within the scope of African Blood Regulators Forum (ABRF), the scope of the forum is to:

  • Promote information sharing and reliance for strengthening and harmonizing regulatory systems for blood products.
  • Provide advocacy and communications targeted to policy makers and the general public to enhance understanding and support of the need for blood regulation.
  • Strengthen capacity of national blood regulators through external assessment against the WHO Global Benchmarking Tool and cooperation in addressing identified gaps and deficiencies.

The training workshop focused on the following special topics for blood establishment inspections:

  • General principles of quality management systems and inspections
  • Regulations and regulatory framework
  • Requirements for buildings, premises, and storage facilities
  • Validation and Qualification, staff training and evaluation
  • Inspection / Internal Audit
  • Change Control / Management and risk assessment

The engagements and the workshop were instrumental in mapping the additional activities for ABRF in supporting the implementation of the African Medicines Agency (AMA), as the ABRF is one of the AMA technical Working Group.

SAHPRA colleagues that were in attendance include SAHPRA CEO Dr Boitumelo Semete-Makokotlela, Manager: Biological Medicines Mr Khamusi Mutoti, Senior Manager: Pharmaceutical Evaluation Ms Silverani Padayachee, Office Manager in the Office of the Chief Regulatory Office Ms Buhle Binta, Office Manager in the Chief Executive’s Office Ms Mukona Mphidi, and Legal Advisor Mr Bongani Ngcobo.

Download PDF