Fda Guidance Quality Systems Approach To Pharmaceutical Current Good Manufacturing Practice Regulations英文电子书.pdf

Guidance for Industry Quality Systems Approach to Pharmaceutical CGMP Regulations U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER) Center for Veterinary Medicine (CVM) Office of Regulatory Affairs (ORA) September 2006 Pharmaceutical CGMPs Guidance for Industry Quality Systems Approach to Pharmaceutical CGMP Regulations Additional copies are available from: Office of Training and Communication Division of Drug Information, HFD-240 Center for Drug Evaluation and Research Food and Drug Administration 5600 Fishers Lane Rockville, MD 20857 (Tel) 301-827-4573 /cder/guidance/index.htm or Office of Communication, Training and Manufacturers Assistance, HFM-40 Center for Biologics Evaluation and Research Food and Drug Administration 1401 Rockville Pike, Rockville, MD 20852-1448 /cber/guidelines.htm. (Tel) 800-835-4709 or 301-827-1800 or Communications Staff, HFV-12 Center for Veter