FDA Guidance for Industry: Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations

https://www.gmp-navigator.com/files/guidemgr/qualsystem.pdf

Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070337.pdf