USP is engaging with internal and external stakeholders to define compendial standards of the future. Our work in this area involves identifying new standards in emerging pharmaceutical development, establishing use and application of new standards, and managing the life cycle of these new standards.
To this end, we are exploring these and other areas such as:
- Pharmaceutical Continuous Manufacturing (PCM)
- Standardization of Digital Health
- Quality by Design
- Personalized Medicine
- 3D Printing
Focus on PCM: Workshop, Expert Panel and C-SOPS Collaboration
USP is actively engaging with PCM academic research center, pharmaceutical innovators, generic manufactures, and regulators to drive PCM standardization efforts and develop collaboration opportunities.
In 2016, a roundtable co-hosted by USP and the Center for Structured Organic Particulate Systems (C-SOPS), was held to help determine how quality standards for drug products and ingredients can contribute to PCM. As an outcome of this workshop, USP formed an Expert Panel on PCM. The panel, which includes experts from academia, industry and regulatory bodies, is examining opportunities for USP to assist in PCM technology improvement through the development of quality standards. Its first endeavors include standardizing terms used in PCM and characterizing materials that are specific to PCM.
To formalize the collaboration between USP and C-SOPS, leaders from both organizations signed a memorandum of understanding (MOU) in February 2017. At the signing event, C-SOPS and USP leaders emphasized the importance of making the PCM technology more affordable and widely available to manufacturers around the world.
As part of our effort to continue engagement with stakeholders and thought leaders, the first USP International PCM Workshop was hosted in India in May 2017. The purpose of the workshop was to provide an open platform for PCM knowledge sharing, and to convene an interactive discussion on key technological and quality challenges and opportunities. Future planned activities include exploring the development of solid dosage standards for PCM and hosting additional workshops to introduce PCM to critical markets and learn about advances in the field, possibly establishing collaborations with other leaders in PCM.
Learn more about USP’s work on PCM and the C-SOPS collaboration through our Quality Matters blog.