The following guideline can be ordered through the address listed in the "Source/Publisher"-category. In cases in which you can order through the Internet we have established a hyperlink.

FDA Guidance for Industry: Q3A Impurities in New Drug Substances, Revision 2

Short Title:

Center for Drug Evaluation and Research; Center for Biologics Evaluation and Research; Food and Drug Administration; 5600 Fishers Lane; Rockville, MD 20857,

Document Type:
Guideline for Industry
This guideline deals with impurities (organic, inorganic and residual solvents) in new active substances and defines limits as of which impurities must be identified or qualified.

Go back

GMP Conferences by Topics