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Strengthening Quality Local Production: The First Week of Quality Wraps Up with Resounding Success [1]

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Date: 2023-06

Manufacturers and regulators from 90 countries worldwide came together each day in the inaugural Week of Quality, organized by WHO's Local Production and Assistance (LPA) Unit, in the Regulation and Prequalification Department (RPQ), within the Access to Medicines and Health Products Division (MHP). Successfully concluding on June 16, 2023, manufacturers and regulators successfully walked away with a deeper understanding of the importance and current issues, trends and regulatory expectations in establishing quality specifications for these medical products.

“It is critical to establish robust specifications, which underpins the quality of vaccines, medicines and in vitro diagnostics (IVDs) being produced”, Dr Jicui Dong, Unit Head of the LPA Unit, remarked at the close of this inaugural global training event. “Ultimately, ensuring quality is to ensure the safety and efficacy of the medical product for the patient.”

With increasing regulatory expectations for manufacturers to build quality into the product, this Week of Quality synergizes with the annual Virtual cGMP Training Marathon to improve capacity to do just that. More than 1500 vaccine & biopharmaceutical manufacturers and regulators attended the 2-day session on vaccine quality specifications. More than 1400 pharmaceutical manufacturers and regulators strengthened their foundations in establishing quality specification for medicines. And for the first time, over 100 IVD manufacturers and regulators built capacity in narrowing the gap between quality specifications of IVDs and design validation.

Here’s what some participants had to say:

"The training has provided me with the best insights of knowledge and skills in vaccine, medicine, and in vitro diagnostics manufacturing. This knowledge will equip me in my day-to-day activities as a regulatory affairs pharmacist. The knowledge and skills obtained will be shared to my organization for the betterment of regulating quality of medicines, vaccines and in vitro diagnostics and attain our goal of promoting public health."

“I am very happy and excited to be able to join this training. Knowledge is directly shared by experts from WHO. This experience will really help me in my work and career in my current company in the future.”



“It was very good experience because, there’s no new development for medicines that we use in Mexico, most of them are very old formulations, and the specs are taken from Pharamacopeias. So it was a good experience”

For further information and inquiries about the Week of Quality or LPA's initiatives, please visit the LPA website contact Dr. Jicui Dong, Unit Head of the LPA Unit, at [email protected], copying [email protected].

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[1] Url: https://www.who.int/news/item/15-06-2023-strengthening-quality-local-production--the-first-week-of-quality--wraps-up-with-resounding-success

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