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PREFACE xiii SECTION 1 GOOD MANUFACTURING PRACTICES (GMP) AND OTHER FDA GUIDELINES 1 1.1 Good Manufacturing Practices (GMPs) and Related FDA Guidelines 3James R. Harris 1.2 Enforcement of Current Good Manufacturing Practices 45Kenneth J. Nolan 1.3 Scale–Up and Postapproval Changes (SUPAC) Regulations 67Puneet Sharma, Srinivas Ganta, and Sanjay Garg 1.4 GMP–Compliant Propagation of Human Multipotent Mesenchymal Stromal Cells 97Eva Rohde, Katharina Schallmoser, Christina Bartmann, Andreas Reinisch, and Dirk Strunk SECTION 2 INTERNATIONAL REGULATIONS OF GOOD MANUFACTURING PRACTICES 117 2.1 National GMP Regulations and Codes and International GMP Guides and Guildelines: Correspondences and Differences 119Marko Närhi and Katrina Nordström SECTION 3 QUALITY 163 3.1 Analytical and Computational Methods and Examples for Designing and Controlling Total Quality Management Pharmaceutical Manufacturing Systems 165Paul G. Ranky, Gregory N. Ranky, Richard G. Ranky, and Ashley John 3.2 Role of Quality Systems and Audits in Phatmaceutical Manufacturing Environment 201Evan B. Siegel and James M. Barquest 3.3 Creating and Managing a Quality Management System 239Edward R. Arling, Michelle E. Dowling, and Paul A. Frankel 3.4 Quality Process Improvement 287Jyh–hone Wang SECTION 4 PROCESS ANALYTICAL TECHNOLOGY (PAT) 311 4.1 Case for Process Analytical Technology: Regulatory and Industrial Perspectives 313Robert P. Cogdill 4.2 Process Analytical Technology 353Michel Ulmschneider and Yves Roggo 4.3 Chemical Imaging and Chemometrics: Useful Tools for Process Analytical Technology 411Yves Roggo and Michel Ulmschneider SECTION 5 PERSONNEL 433 5.1 Personnel Training in Pharmaceutical Manufacturing 435David A. Gallup, Katherine V. Domenick, and Marge Gillis SECTION 6 CONTAMINATION AND CONTAMINATION CONTROL 455 6.1 Origin of Contamination 457Denise Bohrer 6.2 Quantitation of Markers for Gram–Negative and Gram–Positive Endotoxins in Work Environment and as Contaminants in Pharmaceutical Products Using Gas Chromatography–Tandem Mass Spectrometry 533Alvin Fox 6.3 Microbiology of Nonsterile Pharmaceutical Manufacturing 543Ranga Velagaleti SECTION 7 DRUG STABILITY 557 7.1 Stability and Shelf Life of Pharmaceutical Products 559Ranga Velagaleti 7.2 Drug Stability 583Nazario D. Ramirez–Beltran, Harry Rodriguez, and L. Antonio Estévez 7.3 Effect of Packaging on Stability of Drugs and Drug Products 641Emmanuel O. Akala 7.4 Pharmaceutical Product Stability 687Andrew A. Webster 7.5 Alternative Accelerated Methods for Studying Drug Stability: Variable–Parameter Kinetics 701Giuseppe Alibrandi SECTION 8 VALIDATION 725 8.1 Analytical Method Validation: Principles and Practices 727Chung Chow Chan 8.2 Analytical Method Validation and Quality Assurance 743Isabel Taverniers, Erik Van Bockstaele, and Marc De Loose 8.3 Validation of Laboratory Instruments 791Herman Lam 8.4 Pharmaceutical Manufacturing Validation Principles 811E. B. Souto T. Vasconcelos D. C. Ferreira, and B. Sarmento INDEX 839