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Quality Control and Lot Release

Lab Testing

Regulatory laboratory testing is intended to ensure that the Board is able to assess the quality of medical products marketed in Kenya. It is undertaken in order to:

  1. corroboration with manufacturer’s test results as a part of the evaluation for marketing authorization or for a variation to a marketing authorization,
  2. release a lot of vaccines or other biological products,
  3. augment the investigations in cases of products for which there has been a complaint or a report or for products that are under investigation due to an adverse event.
  4. check and confirm the quality of medical products placed on the market and for detecting substandard and falsified medical products as part of the market surveillance function,

In order to do this product testing, the Board has access to the National Quality Control Laboratory and to other suitable external laboratories, either inside or outside the country, to perform the required tests. In all cases, regulatory decisions and actions remain at the discretion of the Board and the Board retains accountability.

Regulatory laboratory testing activities performed in the field or at the regions are performed in accordance with an established continuous information exchange mechanism and centrally issued guidance.

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.