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Guidance for Industry PAT — A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance

The Ethiopian Boran breed is one of the cattle breeds widely used in Ethiopia. The breed is well adapted to semi-arid tropical conditions, has a high degree of heat tolerance, is tolerant to many of the diseases prevailing in the tropics and has the ability to survive long periods of feed and water shortage (Ojango et al. 2006). These properties have genetic basis and have been acquired by natural and human selection over generations. They are all essential for successful animal production in the tropics. While only their superior beef production potential has been the focus of research in many. | Guidance for Industry PAT A Framework for Innovative Pharmaceutical Development Manufacturing and Quality Assurance U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research CDER Center for Veterinary Medicine CVM Office of Regulatory Affairs ORA Pharmaceutical CGMPs September 2004 Guidance for Industry PAT A Framework for Innovative Pharmaceutical Development Manufacturing and Quality Assurance 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 and 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 Veterinary Medicine CVM Office of Regulatory Affairs ORA September 2004 Pharmaceutical CGMPs Contains Nonbinding Recommendations TABLE OF CONTENTS I. INTRODUCTION.1 II. GUIDANCE DEVELOPMENT PROCESS AND SCOPE.2 III. BACKGROUND.2 IV. PAT FRAMEWORK.4 A. Process Understanding.6 B. Principles and Tools.6 1. PAT Tools.7 3. Risk-Based Approach.11 4. Integrated Systems Approach.12 5. Real Time Release.12 C. Strategy for Implementation.12 V. PAT REGULATORY APPROACH.14 .