Establishing quality specifications for medicines, vaccines and in vitro diagnostics – World Health Organization (WHO)

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 Regulation and Prequalification Department (RPQ), Access to Medicines and Health Products Division (MHP), WHO, supports Member States (MS), particularly low- and middle-income countries (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 & 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, 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 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. More than 1700 vaccine and biopharmaceutical manufacturers and regulators attended the sessions on vaccine quality specifications. More than 1400 pharmaceutical manufacturers and regulators strengthened their foundations in establishing quality specifications for medicines. And for the first time, over 1000 IVD manufacturers and regulators, built capacity in narrowing the gap between quality specifications of IVDs and design validation.

Questions raised by manufacturers and regulators in the 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.

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Establishing quality specifications for medicines, vaccines and in vitro diagnostics - World Health Organization (WHO)