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CONTRIBUTORS. PREFACE. SECTION 1 GOOD MANUFACTURING PRACTICES(GMP) AND OTHER FDA GUIDELINES. 1.1 Good Manufacturing Practices (GMPs)and Related FDA Guidelines (James R. Harris). 1.2 Enforcement of CurrentGood Manufacturing Practices (Kenneth J. Nolan). 1.3 Scale-Up andPostapproal Changes (SUPAC) Regulations (Puneet Sharma, Srinivas Ganta, andSanjay Garg). 1.4 GMP-Compliant Propagation of Human MultipotentMesenchymal Stromal Cells (Eva Rohde, Katharina Schallmoser, ChristinaBartmann, Andreas Reinisch, and Dirk Strunk). SECTION 2 INTERNATIONALREGULATIONS OF GOOD MANUFACTURING PRACTICES. 2.1 National GMPRegulations and Codes and international GMP Guides and Guildelines:Correspondences and Differences (Marko Narhi and Katrina Nordstrom).SECTION 3 QUALITY. 3.1 Analytical and Computational Methods and Examplesfor Designing and Controlling total Quality Management PharmaceuticalManufacturing systems (Paul G. Ranky, Gregory N. Ranky, Richard G. Ranky, andAshley John). 3.2 Role of Quality Systems and Audits in PhatmaceuticalManufacturing Environment (Evan B. Siegel and James M. Barquest). 3.3Creating and Managing a Quality Management system (Edward R. Arling, MichelleE. Dowling, and Paul A. Frankel). 3.4 Quality process improement (Jyh-honeWang). SECTION 4 PROCESS ANALYTICAL TECHNOLOGY (PAT). 4.1 Case forProcess Analytical Technology: Regulatory and Industrial Perspectives (RobertP. Cogdill). 4.2 Process Analytical Technology (Michel Ulmschneider, YvesRoggo). 4.3 Chemical imaging and Chemometrics: Useful Tools for ProcessAnalytical Technology (Yves Roggo and Michel Ulmschneider). SECTION 5PERSONNEL. 5.1 Personnel Training in Pharmaceutical Manufacturing (DavidA. Gallup, Katherine V. Domenick, and Marge Gillis). SECTION 6CONTAMINATION AND CONTAMINATION CONTROL. 6.1 Origin of Contamination(Denise Bohrer). 6.2 Quantitation of Markers for Gram-Negatie andGram-Positive Endotoxins in Work Enironment and as Contaminants inPharmaceutical Products Using Gas Chromatography-Tandem Mass Spectrometry(Alvin Fox). 6.3 Microbiology of Nonsterile Pharmaceutical Manufacturing(Ranga Velagaleti). SECTION 7 DRUG STABILITY. 7.1 Stability andShelf Life of Pharmaceutical Products (Ranga Velagaleti). 7.2 DrugStability (Nazario D. Ramirez-Beltran, Harry Rodriguez, and L. AntonioEstevez). 7.3 Effect of Packaging on Stability of Drugs and Drug Products(Emmanvel O. Akala). 7.4 Pharmaceutical Product Stability (Andrew A.Webster). 7.5 Alternative Accelerated Methods for Studying Drug Stability:Variable-Parameter Kinetics (Giuseppe Alibrandi). SECTION 8 VALIDATION.8.1 Analytical Method Validation: Principles and Practices (Chung ChowChan). 8.2 Method Validation and Quality Assurance (Isabel Taverniers,Erik Van Bockstaele, and Marc De Loose). 8.3 Validation of LaboratoryInstruments (Herman Lam). 8.4 Pharmaceutical Manufacturing ValidationPrinciples (E. B. Souto T. Vasconcelos D. C. Ferreira, and B. Sarmento).Index.