FDA to Accept Supplier Data, Statements on Solvents
The suppliers’ analytical reports must show the components comply with the U.S. Pharmacopeia (USP) General Chapter <467> requirement for control of residual solvents, according to the guidance. If the test limits are met for the drug product components, finished product testing is unnecessary, it says.
The guidance, intended to help manufacturers comply with the USP requirement, tells manufacturers with new drug applications and
abbreviated new drug applications for noncompendial drug products to refer to International Conference on Harmonisation “Guidance for Industry Q3C Impurities: Residual
Solvents” for recommendations on solvent classification and permitted daily exposure.
Drug GMP Report