Pharmacopeia

Mar 23, 2020

Organizations interested in taking advantage of this resource should contact USP as soon as possible: We call on stakeholders to designate a point of contact from their organization with whom we can discuss how we will work as a community with the goal of creating an environment for enhanced information sharing and partnering to facilitate solutions to address the pandemic. USP will work with stakeholders developing viral testing strategies, antiviral therapies, and vaccines, as well as experts from global regulatory bodies and public health agencies (e.g., Centers of Disease Control, U.S. Food and Drug Administration, World Health Organization). USP scientific teams are prepared to assist with solutions in numerous areas. Examples include: Best practices that are broadly applicable to manufacturing and testing strategies and are aligned with global regulatory guidelines; includes test methods and procedures (e.g., sterility testing, bacterial contamination control) that can be used to manage regulatory expectations; Qualification of excipients and raw materials to be used in manufacturing ; Our collection of USP Reference Standards which contain materials to demonstrate the suitability of the methods and can also be used for the development and validation of analytical methods; Technical assistance to those who are interested in following our processes and use our standards. We are happy to engage in further dialog with stakeholders to ensure that their approaches to analytical methods can meet compendial and regulatory expectations.