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.
Q7A Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients
Center for Drug Evaluation and Research; Center for Biologics Evaluation and Research; Food and Drug Administration; 5600 Fishers Lane; Rockville, MD 20857; http://www.fda.gov/cder/guidance/index.htm
Content:
Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients