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Regulation and Prequalification
Progress towards enhancing regulatory practices related to medical products around the world is supported by capacity building, promoting regulatory convergence and harmonization.

Local production and technical transfer can play a significant role towards the reliable supply of safe, quality-assured, affordable health products. However, local manufacturers in Low- and Middle-Income Countries (LMICs), in most cases, manufacture below their optimal capacity and supply only a fraction of the local market for a variety of reasons. This has been exacerbated by limited technical and technological capacity both in the industry and regulators, and the imbalance between regulatory coverage and the number of local manufacturers. Industry and regulators have concurrent roles to ensure quality access to quality health products.

To provide sustainable solution and curb the limitations encountered by LMICs, The Local Production & Assistance Unit (LPA) organizes a set of regional training workshop for manufacturers, regulators, and other stakeholders in different regions to build capacity in leveraging on key enablers for sustainable and quality local production. Moreover, a global knowledge repository of trainings and other resources to promote local production and technology transfer is being developed. Such repository includes model strategies, tools, Q&As reports on specific cGMP topics and guidance, directed to governments, the industry, and other stakeholders. The LPA Unit organizes regular cGXP trainings to build capacity of manufacturers in all 6 WHO regions.


Virtual cGMP Training Marathon

There is a need for local manufacturers in many LMICs to build capacity in producing quality-assured medical products to help improve access and strengthen medical products security. In response to Member States’ requests for support to address this need, the Local Production & Assistance Unit (LPA) organizes Virtual cGMP Training Marathons in a yearly basis to provide concepts on selected cGMP topics, facility design, technology transfer and Quality Management System skills aimed at managing current regulatory expectations for medical products manufacturing. 

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Week of Quality

The Week of Quality, an annual event presented by the Local Production and Assistance Unit (LPA) with financial support from Bill & Melinda Gates Foundation, is dedicated to recognizing the pivotal role of quality in the pharmaceutical and IVD industries. The Week of Quality aims to promote knowledge exchange, best practices, and sustainable local production in LMICs, fostering a deeper understanding of quality and CMC standards among manufacturers to enhance product quality and applications in the healthcare sector. Join us in elevating standards and excellence in healthcare products.

Week of Quality 2024
Week of Quality 2023

Capacity building events

Holistic Capacity Building for Sustainable Local Production