
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.
/regulation-and-prequalification-(rpq)/local-production-and-assistance-(lpa)/cgmp-training-marathon-2025_long_imageweb2d686f97151e43d4bcdf0b74888d50da.tmb-1920v.jpg?sfvrsn=33762c99_1)


Enhancing compliance to good manufacturing practices and pharmaceutical quality system...



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.


Establishing quality specifications for medicines, vaccines and in vitro diagnostics:...
Capacity building events
