Guidance for Industry - quality systems approach to pharmaceutical cGMP regulations

Guidance for Industry - quality systems approach to pharmaceutical cGMP regulations

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Unformatted text preview: 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 http://www.fda.gov/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 http://www.fda.gov/cber/guidelines.htm. (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 http://www.fda.gov/cvm/guidance/published.html 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 CGMP Regulations Contains Nonbinding Recommendations TABLE OF CONTENTS I. INTRODUCTION............................................................................................................. 1 II. BACKGROUND AND PURPOSE.................................................................................. 1 A. Background ....................................................................................................................................1 B. Goal of the Guidance .....................................................................................................................2 C. Scope of the Guidance ...................................................................................................................3 D. Organization of this Guidance......................................................................................................4 III. CGMPS AND THE CONCEPTS OF MODERN QUALITY SYSTEMS................... 4 A. Quality.............................................................................................................................................4 B. Quality by Design and Product Development .............................................................................4 C. Quality Risk Management ............................................................................................................5 D. CAPA (Corrective and Preventive Action)..................................................................................5 E. Change Control..............................................................................................................................5Change Control....
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This note was uploaded on 01/01/2012 for the course PHAR 6010 taught by Professor Mullis during the Spring '11 term at University of Georgia Athens.

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Guidance for Industry - quality systems approach to pharmaceutical cGMP regulations

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