quality systems approach to pharmaceuticals cGMP.pdf

Guidance for Industry
Quality Systems Approach to
Pharmaceutical CGMP Regulations






















. 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 munication
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
r/guidance/

or

Office munication, Training and
Manufacturers Assistance, HFM-40
Center for Biologics Evaluation and Research
Food and Drug Administration
1401 Rockville Pike, Rockville, MD 20852-1448
r/.
(Tel) 800-835-4709 or 301-827-1800

or

Communications Staff, HFV-12
Center for Veterinary Medicine
Food and Drug Administration
7519 Standish Place, Rockville, MD 20855
(Tel) 301-827-3800
/guidance/

. 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 CGMP Regulations
Contains Nonbinding mendations




TABLE OF CONTENTS


I. INTRODUCTION............................................................................................................. 1
II. BACKGROUND AND PURPOSE.................................................................................. 1
A. Background ........................................