Pharmaceutical Manufacturing Handbook / Pharmaceutical Development Bd.2 (PDF)

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 Current Good Manufacturing Practices (Kenneth J. Nolan). 1.3 Scale-Up and Postapproal Changes (SUPAC) Regulations (Puneet Sharma, Srinivas Ganta, and Sanjay Garg). 1.4 GMP-Compliant Propagation of Human Multipotent Mesenchymal Stromal Cells (Eva Rohde, Katharina Schallmoser, Christina Bartmann, Andreas Reinisch, and Dirk Strunk). SECTION 2 INTERNATIONAL REGULATIONS OF GOOD MANUFACTURING PRACTICES. 2.1 National GMP Regulations and Codes and international GMP Guides and Guildelines: Correspondences and Differences (Marko Närhi and Katrina Nordström). SECTION 3 QUALITY. 3.1 Analytical and Computational Methods and Examples for Designing and Controlling total Quality Management Pharmaceutical Manufacturing systems (Paul G. Ranky, Gregory N. Ranky, Richard G. Ranky, and Ashley John). 3.2 Role of Quality Systems and Audits in Phatmaceutical Manufacturing Environment (Evan B. Siegel and James M. Barquest). 3.3 Creating and Managing a Quality Management system (Edward R. Arling, Michelle E. Dowling, and Paul A. Frankel). 3.4 Quality process improement (Jyh-hone Wang). SECTION 4 PROCESS ANALYTICAL TECHNOLOGY (PAT). 4.1 Case for Process Analytical Technology: Regulatory and Industrial Perspectives (Robert P. Cogdill). 4.2 Process Analytical Technology (Michel Ulmschneider, Yves Roggo). 4.3 Chemical imaging and Chemometrics: Useful Tools for Process Analytical Technology (Yves Roggo and Michel Ulmschneider). SECTION 5 PERSONNEL. 5.1 Personnel Training in Pharmaceutical Manufacturing (David A. Gallup, Katherine V. Domenick, and Marge Gillis). SECTION 6 CONTAMINATION AND CONTAMINATION CONTROL. 6.1 Origin of Contamination (Denise Bohrer). 6.2 Quantitation of Markers for Gram-Negatie and Gram-Positive Endotoxins in Work Enironment and as Contaminants in Pharmaceutical Products Using

SHAYNE COX GAD, PhD, DABT, ATS, is the Principal of Gad Consulting Services. Dr. Gad has more than thirty years of experience as a toxicologist, statistical consultant, manager, and general consultant on research and development in the chemical, consumer product, contract testing, biotechnology, medical device, and pharmaceutical industries. He is the author of twenty-nine books and numerous papers, presentations, and other publications.

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