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PHARMACEUTICAL MANUFACTURING HANDBOOK

SECTION 1 GOOD MANUFACTURING PRACTICES (GMP) AND OTHER FDA GUIDELINES 1 1.1 Good Manufacturing Practices (GMPs) and Related FDA Guidelines 3. James R. Harris. 1.2 Enforcement of Current Good Manufacturing Practices 45. Kenneth J. Nolan. 1.3 Scale-Up and Postapproval Changes (SUPAC) Regulations 67. Puneet Sharma, Srinivas Ganta, and Sanjay Garg

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What is Process Validation?

May 12, 2011· 1. Process Design: The commercial process is defined during this stage based on knowledge gained through process development activities. 2. Process Qualification: During this stage, the process design is confirmed as being capable of reproducible commercial manufacturing. Including qualification of the facility, utilities and equipment. 3.

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Manufacturing Processes, Second Edition

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Contents Preface to the Third Edition xiii 1. Introduction 1 1.1 Introduction to Material-Removal Processes 1 1.2 Variety of Machine Tools 2 2 Metal Cutting 5 2.1 Introduction 5 2.2 Chip Formation 7 2.3 Shear Zone 10 2.4 Orthogonal Cutting 10 2.5 Shear Angle and its Relevance 22 2.6 Cutting-Tool Geometry 25 2.7 Dynamometers 30 2.8 Cutting-Tool Materials 32 2.9 Thermal Aspects 44 2.10 Tool Wear ...

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