Today marks the commencement of the highly anticipated Week of Quality, organized by the Local Production and Assistance (LPA) Unit in the Regulation and Prequalification Department (RPQ), in the Access to Medicines and Health Products Division (MHP), at WHO Headquarters, with financial support from the Bill & Melinda Gates Foundation (BMGF). Dr Yukiko Nakatami, Assistant Director-General for the MHP Division, opened this inaugural event with insightful remarks, highlighting human capital with appropriate knowledge and skills as a key ingredient to achieve sustainable quality local production to improve access. After the opening, Dr Jicui Dong, Unit Head of the LPA Unit, stated that the Week of Quality complements the annual Virtual cGMP Training Marathon to ensure quality production and supply throughout the entire product life cycle. This event marks a significant milestone in emphasizing the paramount importance of quality in the local production of vaccines, medicines, and in vitro diagnostics (IVD).
Under the theme "On the origin of specifications," the Week of Quality 2023 is dedicated to establishing rigorous standards that ensure the release of safe, effective, and high-quality vaccines, medicines, and IVDs. Today, we embark on this transformative journey with a multitude of participants from various countries across all six WHO regions.
We are delighted to report that more than 1700 participants, hailing from diverse backgrounds and expertise, have joined us on this inaugural day. Their presence will contribute to the collective effort of advancing quality in health products’ manufacturing industry.
The Week of Quality focuses on quality specification to address the unique challenges brought by the COVID-19 pandemic in the production of medicines, vaccines, and in vitro diagnostic products. The surge in demand and the need to increase production capacity have heightened the importance of maintaining stringent quality control measures. By emphasizing quality specifications, the Week of Quality aims to ensure that medical products released during and beyond the pandemic are safe, effective, and of high quality.
Throughout the Week of Quality, attendees will receive valuable guidance on quality data requirements, Chemistry, Manufacturing, and Control (CMC) standards. Expert sessions will delve into crucial topics, including patient-centric specifications, and manufacturing consistency, such as to ensure that product quality expectations are met.
The ultimate aim of the Week of Quality is to strengthen sustainable local production in low- and middle-income countries (LMICs). By equipping manufacturers with profound understanding of quality and CMC standards, we empower them to enhance product quality, improve applications, and optimize access to high-quality health products.
For further information and inquiries, please contact Dr. Jicui DONG, Unit Head, LPA Unit, at dongj@who.int, copying localproduction@who.int.