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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 – information related to a potential standard not yet under development – is shared through our website to engage and empower stakeholders, like you, to help shape these potential standards through discussion and exchange of information.  

Click here to learn more about emerging standards.

 

Paradigm Shift in Drug Development
Paradigm Shift in Drug Development

Paradigm Shift in Drug Development: Analytical Quality by Design and Analytical Procedure Life Cycle

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When it comes to drug development and manufacturing, impurities can pose very serious risks if undetected or improperly controlled within acceptable limits. Impurities and contaminants discovered during manufacturing can delay product approvals and batch release. Impurities detected in drug products already on consumer shelves can trigger drug recalls and prompt regulatory actions. In a recently released analysis of US FDA reported drug recall data (2012-2023), the most frequent cause of recalls was found to be impurities and contaminants.1

1 Seppe Ghijs et al, “The continuing challenge of drug recalls: Insights from a ten-year FDA data analysis,” Journal of Pharmaceutical and Biomedical Analysis, Oct 2024

The Emerging Standards Concept
The Emerging Standards Concept

 

The Emerging Standards Concept

USP's iterative approach to standards development

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When it comes to drug development and manufacturing, impurities can pose very serious risks if undetected or improperly controlled within acceptable limits. Impurities and contaminants discovered during manufacturing can delay product approvals and batch release. Impurities detected in drug products already on consumer shelves can trigger drug recalls and prompt regulatory actions. In a recently released analysis of US FDA reported drug recall data (2012-2023), the most frequent cause of recalls was found to be impurities and contaminants.1

1 Seppe Ghijs et al, “The continuing challenge of drug recalls: Insights from a ten-year FDA data analysis,” Journal of Pharmaceutical and Biomedical Analysis, Oct 2024

nitrosamine impurities in medicines
nitrosamine impurities in medicines

Safeguarding patients from nitrosamine impurities in medicines

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scientist in lab
Evolving approaches to standards

USP is continually evolving its approaches to developing up-to-date, science-based public standards that serve as quality benchmarks for medicines dietary supplements and foods.

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injecting a cell
Emerging modalities of medicines

USP is exploring new technologies and treatments, from personalized medicines to cell and gene therapies, that are revolutionizing medicine and changing the way quality standards are created.

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New manufacturing and analytical technologies 

USP is studying new manufacturing and analytical technologies that could lead to big improvements in the production of and access to medicines.

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inhaler
Performance of drug substances and products

USP’s approach to performance standards, from dissolution test methods to standards for metered dose inhalers, is critical to helping ensure whether a medicine delivers the expected therapeutic effect.

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remdesivir antiviral drug
remdesivir antiviral drug

Trust in COVID-19 Medicine: USP Methods to Assist in Detecting Falsified Remdesivir

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Collaborations in Science

USP is committed to collaborating with other scientific thought leaders to address current public health challenges and improve the quality of and access to medicines worldwide. 

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Student fellowships and programs

Explore emerging technologies and trends in pharmaceutical science and learn more about the development of quality standards for medicines, dietary supplements and food ingredients.

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Scientific careers

Make a positive difference to public health and improve your skills as a scientist. USP brings a diverse and talented workforce with one goal: creating a healthier world.

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Gigi Davidson