IPEC e-newsletter - Excipients Insight October 2018 - 31-10-18


Inside this issue


New USP project tackles impurities in pharma development

USP has launched a new programme to assist manufacturers in their drug development efforts, entitled Impurities for Development (IfD). The aim is to help pharmaceutical manufacturers meet quality standards and regulatory requirements to control impurities that may be harmful to patients’ health.

Characterising and controlling impurities in drugs under development can present significant challenges to manufacturers because they can occur for several reasons: arising naturally within the source materials, being added as part of a product’s synthesis, occurring inadvertently during processing and manufacturing, or forming during the shelf life of the product.

USP says it new IfD program aims to help pharmaceutical manufacturers with custom-designed services to identify, isolate, synthesize and characterize impurities in medicines under development, allowing manufacturers to focus on other development processes. Prior to its launch, the IfD program was piloted for nine months with several companies.

More information here.




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