An MD&DI February 1997 Feature Article
FDA Makes Quality the Rule (continued)
14. REFERENCES
1. "Guideline on General Principles of Process Validation," Rockville, MD, FDA, Center for Drugs and Biologics and Center for Devices and Radiological Health (CDRH), 1987.
2. Compliance Policy Guide, Rockville, MD, FDA, CDRH, Office of Compliance, 1987.
