www.fdanews.com/articles/122517-fda-to-accept-supplier-test-data-statements-on-residual-solvents
FDA to Accept Supplier Test Data, Statements on Residual Solvents
November 27, 2009
The FDA’s final guidance on
residual solvents differs from the draft version by permitting manufacturers to submit test data or statements on the solvents from qualified suppliers
of drug components. The suppliers’ reports of analysis must
show the components comply with the U.S. Pharmacopeia General Chapter <467> requirement for control of residual solvents, according to the guidance
published in the Federal Register last week.
Drug Industry Daily
Drug Industry Daily