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USP technical advisors will offer assistance to drug developers to ensure material quality and testing.
The US Pharmacopeia (USP) is offering free technical assistance to developers of antiviral drugs and vaccines and experts from regulatory authorities to combat the COVID-19 pandemic. The organization’s scientific teams are available to help drug developers ensure the quality of materials during scale up and to design tests to ensure the quality of materials, according to a March 18, 2020 statement.
USP also will offer support for manufacturers of treatments for secondary implications of the outbreak, such as bacterial infections.
Available assistance includes test methods to meet regulatory expectations, qualification of excipients and raw materials to be used in manufacturing; USP Reference Standards, which can be used to demonstrate the suitability of methods and for the development and validation of analytical methods; and technical assistance to those interested in following USP processes and use USP standards.
In addition, USP is making select published monographs and General Chapters available for free.