Today’s rapidly evolving, and increasingly complex pharmaceutical landscape requires new approaches to the development of quality standards.
As part of these efforts, USP is proposing a more iterative approach to standards development, where an emerging standard – a standard still under development – is shared on our website to engage and empower stakeholders, like you, to help shape these standards through discussion and exchange of information.
To learn more, click here.
Examples of the flexibility USP employs in its approach to developing standards and guidelines include:
- Risk-based approaches that take into consideration each environment and the need for more or less intensive testing protocols:
- Performance-based approaches are standards that provide minimum analytical procedure performance requirements, which facilitate the applicability to different products and switching to other technologies:
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Understanding Quality Paradigm Shifts in the Evolving Pharmaceutical Landscape: Perspectives from the USP Quality Advisory Group.
Recent advancement in pharmaceutical science is creating changes in the paradigms that have been dominating the industry for decades. New therapeutic modalities and the evolution of manufacturing techniques is challenging our regulatory framework and pharmacopeias. Furthermore, the COVID-19 crisis has emphasized the need to adopt practices that better promote global supply chain resilience. In a recently published white paper, the USP Quality Advisory Group explores the impact of these paradigm shifts in pharmaceutical quality and the approaches that are being taken to adapt to this new environment. Click here to read the white paper.
