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Informationen zum Autor 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. Klappentext Everything you need to ensure full compliance and superior quality controlWith its coverage of Food and Drug Administration regulations, international regulations, good manufacturing practices, and process analytical technology, this handbook offers complete coverage of the regulations and quality control issues that govern pharmaceutical manufacturing. In addition, the book discusses quality assurance and validation, drug stability, and contamination control, all key aspects of pharmaceutical manufacturing that are heavily influenced by regulatory guidelines.The team of expert authors, all familiar with the many issues involved in compliance and quality control, offer you advice based on their own firsthand experience in all phases of pharmaceutical manufacturing. The editor, who has more than thirty years' experience working with pharmaceutical and biotechnology companies, carefully reviewed all the chapters to ensure that each one is thorough, accurate, and clear.Among the key topics covered are:*Enforcement of current good manufacturing practices*Inspections by health regulatory agencies*Creating and managing a quality management system*Personnel training within pharmaceutical manufacturing*Microbiology of non-sterile pharmaceutical manufacturing*Pharmaceutical manufacturing validation principlesFollowing the handbook's carefully developed guidelines and advice helps you ensure your company's full compliance and avoid potential costly pitfalls. This publication should be readily accessible to all scientists, engineers, and managers involved in pharmaceutical manufacturing. Zusammenfassung With its coverage of Food and Drug Administration regulations, international regulations, good manufacturing practices, and process analytical technology, this handbook offers complete coverage of the regulations and quality control issues that govern pharmaceutical manufacturing. Inhaltsverzeichnis PREFACE xiii 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 1.4 GMP-Compliant Propagation of Human Multipotent Mesenchymal Stromal Cells 97 Eva 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 119 Marko 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 165 Paul G. Ranky, Gregory N. Ranky, Richard G. Ranky, and Ashley John 3.2 Role of Quality Systems and Audits in Phatmaceutical Manufacturing Environment 201 Evan B. Siegel and James M. Barquest 3.3 Creating and Managing a Quality Management System 239 Edward R. Arling, Michelle E. Dowling, and Paul A. Frankel 3.4 Quality Process Improvement 287 Jyh-hone Wang SECTION 4 PROCESS ANALYTICAL TEC...
