ABSTRACT
Artificial intelligence is transforming the pharmaceutical sector through improvement in critical processes such as quality assurance (QA). However, in Kenya, technical problems in QA processes, including in‐process quality control, equipment maintenance, and visual inspections exist. This paper aims to shed light on the potential of AI in improving pharmaceutical QA in Kenya and challenges associated with its integration. A literature search was thoroughly conducted by retrieving articles from Google Scholar. Articles and policy documents with information relevant to AI applications in QA, optimising pharmaceutical processes, and regulatory compliance in Kenya were reviewed and analysed. AI can improve efficiency and precision in various QA processes including warehousing, equipment maintenance, in‐process quality control, and visual inspections, among others. Significant challenges to AI incorporation in QA of Kenya's pharma companies include a lack of technical expertise and understanding of AI outcomes, high implementation costs and fear of losing jobs. There should be strengthened collaborations among government, pharmaceutical manufacturers, AI companies, and researchers to address skill‐based barriers and financial challenges.