Building Local Expertise in Quality Control and Lot Release – VaccRelease Conducts First Training Sessions
In its first project year of 2023, the VaccRelease team trained laboratory staff from the partner countries of Rwanda, South Africa, and Ghana in official lot release of vaccines. Two of these training sessions took place at the Paul-Ehrlich-Institute, and the third was conducted virtually. They served to build skills but also to better understand the needs of the respective authorities.
The VaccRelease project supports African partner countries in establishing reliable official lot release to monitor the safety of vaccine lots. This includes:
- technical advice on analysing weaknesses using the WHO Global Benchmarking Tool,
- developing country-specific regulatory structures such as regulations, guidelines, and standard operating procedures,
- building competencies as needed.
Training of a total of 29 regulators in 2023
The training aimed at capacity building in the regulatory release of vaccine lots and took place at different sites. The first one was facilitated in July 2023 with five employees of the Rwanda Food and Drugs Authority (Rwanda FDA). In August 2023, there was another training with three representatives of the South African Health Products Regulatory Authority (SAHPRA). Both were hosted on site at the Paul-Ehrlich-Institute (PEI) in Langen. In November, the training took place virtually with 21 employees of the Ghana Food and Drugs Authority (FDA Ghana) participating.
The on-site training sessions also served to identify specific country needs
‘We conduct the training sessions individually with the authorities because the needs of our partner countries are very different. Through dialogue we can get to know them in detail and create a tailor-made training program,’ says Dr Heidi Meyer. She is VaccRelease Project Lead and Head of the Centre for International Cooperation, WHO at PEI. All the first training sessions provided an overview of lot release and experimental testing at the PEI and in the European Union. Furthermore, they delivered insights into the documents that manufacturers are required to submit to the regulatory authority with the lot release application. For example, this includes the manufacturer’s lot release protocol, which must include all relevant quality data and detection methods for the vaccine. One focus of the training sessions was the official review of these lot release protocols as it forms an essential part of the official control of quality data. Participants learned about the critical issues that need to be considered for different vaccines – microbial or viral. Besides, the necessary regulatory measures to be taken when the quality data requirements are not met or if lots need to be recalled were discussed.
Further training courses in 2024 and 2025 will focus on both, the processes to be established and specific control tests for different vaccines. These will take the form of a series with practical guidance from PEI experts.
Dates of training events:
- Rwanda Food and Drugs Authority (RFDA), at PEI: 17th – 21st July 2023
- South African Health Products Regulatory Authority (SAHPRA), at PEI: 21st – 25th August 2023
- Ghana Food and Drugs Authority (Ghana FDA), online: 1st – 2nd November 2023
