Today’s rapidly evolving and increasingly complex pharmaceutical landscape requires new approaches to the development of quality standards.1
As part of these efforts, USP is proposing to take a more iterative approach to standards development, where an emerging standard – a standard still under development -- is shared through our website to help build stakeholder communities and stimulate early discussion and contribution.
This approach provides greater visibility into the development process while giving you as the stakeholder, an opportunity to shape standards from an early stage. For example, we include the validation and other scientific data on which an emerging standard is based, which gives you, the stakeholder, the ability to understand and respond to this data. Emerging standards may also be accompanied by the release of reference materials, which help you to evaluate and contribute to a potential standard. The transparent nature of this approach allows you to better understand, react to and plan for implementation of an emerging standard, providing greater predictability and certainty for both manufacturers and regulators.
Jn Weitzel, J., Pappa, H., Banik, G.M. et al. Understanding Quality Paradigm Shifts in the Evolving Pharmaceutical Landscape: Perspectives from the USP Quality Advisory Group. AAPS J 23, 112 (2021).