FDA to Accept Supplier Data, Statements on Solvents

The FDA’s final guidance on residual solvents, unlike the draft version, permits manufacturers to submit test data or statements on the solvents from qualified suppliers of drug components to show control of residual solvents in finished drug products.

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