Overview
Ensuring quality of the health product ensures its safety and efficacy. Manufacturers in lowand middle-income countries (LMICs) face challenges to achieve quality in local production,
such as the lack of an available manufacturing workforce trained in quality and understanding
regulatory quality standards and difficulties in implementing a quality culture in the
manufacturing facility.
The Local Production and Assistance (LPA) Unit in the Innovation and Emerging Technologies
Department (IET), Access to Medicines and Health Products Division (MHP), WHO, supports
Member States (MS), particularly LMICs, to strengthen sustainable local production and
technology transfer to improve timely, equitable access to quality, safe and effective essential
medical products. The LPA Unit provides assistance and support to MS with an ecosystem wide and holistic approach, such as conducting ecosystem assessments for sustainable,
quality local production, developing and implementing strategies, roadmaps and tools,
providing comprehensive capacity building and technical assistance, including for WHO
Prequalification (PQ)/Emergency Use Listing (EUL), and facilitating technology transfer (TT).
To support MS to overcome challenges to locally produce quality-assured vaccines and
biotherapeutics, medicines and in vitro diagnostics (IVDs), the LPA Unit organized a new
global training event – Week of Quality – to complement the annual Virtual cGMP Training
Marathons also organized by the LPA Unit. The first Week of Quality was organized from 16 to
20 June 2023 and focused on establishing quality specifications of vaccines, medicines and
IVDs based on WHO and other international guidelines, one of the stepping stones to
achieve quality. The second week of quality took place from 15 April to 13 June 2024 and
focused on exploring key aspect of regulatory compliance for Medicines, IVDs and Vaccines
and biotherapeutics. More than 1700 vaccine and biopharmaceutical manufacturers and
regulators attended the sessions on key aspects of vaccine and biotherapeutic
regulatory compliance. More than 1400 pharmaceutical manufacturers and
regulators strengthened their knowledge on quality requirements for pharmaceutical
product development.
And for the first time, over 1000 IVD manufacturers and
regulators, built capacity in principles of design, quality and compliance for optimizing IVD
product development.
Questions raised by manufacturers and regulators in the second Week of Quality have been
assembled in this training material with questions-and-answers (Q&A) with answers prepared
and peer-reviewed by experts with long and rich experience in the vaccine, medicine or IVD
industry, national regulatory authority (NRA), and other organizations. This document has
been developed to provide manufacturers and other relevant stakeholders with a continuous
learning resource and reference document to acquire new and fortify existing, knowledge
and capacities to strengthen the local production of quality vaccines, medicines and IVDs.