Guía Para La Industria De Sistemas De Calidad

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 IndustryQuality 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 andManufacturers 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) 301-827-3800http://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. II.A. B. C. D.

INTRODUCTION............................................................................................................. 1 BACKGROUND AND PURPOSE.................................................................................. 1
Background .................................................................................................................................... 1Goal of the Guidance ..................................................................................................................... 2 Scope of the Guidance ................................................................................................................... 3 Organization of thisGuidance...................................................................................................... 4

III.
A. B. C. D. E. F. G.

CGMPS AND THE CONCEPTS OF MODERN QUALITY SYSTEMS ................... 4
Quality............................................................................................................................................. 4 Quality by Design and Product Development............................................................................. 4 Quality Risk Management ............................................................................................................ 5 CAPA (Corrective and Preventive Action).................................................................................. 5 Change Control.............................................................................................................................. 5 The Quality Unit ............................................................................................................................ 5 Six-system Inspection Model......................................................................................................... 6

IV.
A. 1. 2. 3. 4. 5. B. 1. 2. 3. 4. C. 1. 2. 3. 4. D. 1. 2. 3. 4.

THE QUALITY SYSTEMSMODEL............................................................................. 8
Management Responsibilities ....................................................................................................... 8 Provide Leadership.......................................................................................................................... 8 Structure the Organization...