USP is actively engaging with academic research center, pharmaceutical innovators, generic manufactures, and regulators to drive Pharmaceutical Continuous Manufacturing (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. USP also continues to engage with PCM stakeholders and thought leaders, with 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.
The first USP stimuli article discussing the current status of regulatory expectations that are specific to PCM and a view of the existing regulatory framework from a PCM perspective is available for public comment. Questions and comments can be done through Pharmacopeial Forum until March 31, 2019 or by email to Edmond Biba at firstname.lastname@example.org.