Quality Control and Lot Release
Lab Testing
The Pharmacy and Poisons Board conducts regulatory laboratory testing to ensure the quality of medical products marketed in Kenya. This testing corroborates manufacturer test results during marketing authorisation processes, facilitates the regulatory lot release of vaccines and biological products, supports investigations of complaints and adverse events, and confirms the quality of medical products on the market as part of market surveillance to detect substandard and falsified products.
To achieve this, the Board utilizes the National Quality Control Laboratory (NQCL) and other accredited external laboratories within and outside Kenya. These collaborations enhance testing capabilities while ensuring that all regulatory decisions and accountability remain solely with the Board. Field and regional testing activities follow centrally issued guidance and leverage a continuous information exchange mechanism to ensure consistency. This integrated approach underscores the Board’s commitment to safeguarding public health by verifying the quality and safety of medical products.
Lot Release
Regulatory lot release of vaccines is part of the regulation of vaccines and involves the independent assessment of each lot of license vaccines before it is released onto the Kenyan market. To ensure the quality, safety, and efficacy of biological products, the Pharmacy and Poisons Board has established a regulatory lot release system that is specifically designed for the regulatory release of vaccines marketed in Kenya. Necessary policies, guidelines, procedures, and forms have been developed and implemented in line with World Health Organization recommendations.
In the case of vaccines, different approaches are currently used for conducting lot release including review of the summary protocols only, review of the summary protocols combined with independent testing, and recognition and acceptance of lot release certificates from the responsible National Regulatory Authority.
Applicants (Manufacturers, Market Authorisation Holders, and importers) are expected to make online applications for regulatory lot release of vaccines intended to be supplied into the Kenyan market on the lot release portal.