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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. 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 offer you advice based on their own firsthand experience in all phases of pharmaceutical manufacturing.…mehr
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. 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 offer you advice based on their own firsthand experience in all phases of pharmaceutical manufacturing.
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Autorenporträt
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.
Inhaltsangabe
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 TECHNOLOGY (PAT) 311 4.1 Case for Process Analytical Technology: Regulatory and Industrial Perspectives 313 Robert P. Cogdill 4.2 Process Analytical Technology 353 Michel Ulmschneider and Yves Roggo 4.3 Chemical Imaging and Chemometrics: Useful Tools for Process Analytical Technology 411 Yves Roggo and Michel Ulmschneider SECTION 5 PERSONNEL 433 5.1 Personnel Training in Pharmaceutical Manufacturing 435 David A. Gallup, Katherine V. Domenick, and Marge Gillis SECTION 6 CONTAMINATION AND CONTAMINATION CONTROL 455 6.1 Origin of Contamination 457 Denise 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 533 Alvin Fox 6.3 Microbiology of Nonsterile Pharmaceutical Manufacturing 543 Ranga Velagaleti SECTION 7 DRUG STABILITY 557 7.1 Stability and Shelf Life of Pharmaceutical Products 559 Ranga Velagaleti 7.2 Drug Stability 583 Nazario D. Ramirez-Beltran, Harry Rodriguez, and L. Antonio Estévez 7.3 Effect of Packaging on Stability of Drugs and Drug Products 641 Emmanuel O. Akala 7.4 Pharmaceutical Product Stability 687 Andrew A. Webster 7.5 Alternative Accelerated Methods for Studying Drug Stability: Variable-Parameter Kinetics 701 Giuseppe Alibrandi SECTION 8 VALIDATION 725 8.1 Analytical Method Validation: Principles and Practices 727 Chung Chow Chan 8.2 Analytical Method Validation and Quality Assurance 743 Isabel Taverniers, Erik Van Bockstaele, and Marc De Loose 8.3 Validation of Laboratory Instruments 791 Herman Lam 8.4 Pharmaceutical Manufacturing Validation Principles 811 E. B. Souto T. Vasconcelos D. C. Ferreira, and B. Sarmento INDEX 839
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 TECHNOLOGY (PAT) 311 4.1 Case for Process Analytical Technology: Regulatory and Industrial Perspectives 313 Robert P. Cogdill 4.2 Process Analytical Technology 353 Michel Ulmschneider and Yves Roggo 4.3 Chemical Imaging and Chemometrics: Useful Tools for Process Analytical Technology 411 Yves Roggo and Michel Ulmschneider SECTION 5 PERSONNEL 433 5.1 Personnel Training in Pharmaceutical Manufacturing 435 David A. Gallup, Katherine V. Domenick, and Marge Gillis SECTION 6 CONTAMINATION AND CONTAMINATION CONTROL 455 6.1 Origin of Contamination 457 Denise 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 533 Alvin Fox 6.3 Microbiology of Nonsterile Pharmaceutical Manufacturing 543 Ranga Velagaleti SECTION 7 DRUG STABILITY 557 7.1 Stability and Shelf Life of Pharmaceutical Products 559 Ranga Velagaleti 7.2 Drug Stability 583 Nazario D. Ramirez-Beltran, Harry Rodriguez, and L. Antonio Estévez 7.3 Effect of Packaging on Stability of Drugs and Drug Products 641 Emmanuel O. Akala 7.4 Pharmaceutical Product Stability 687 Andrew A. Webster 7.5 Alternative Accelerated Methods for Studying Drug Stability: Variable-Parameter Kinetics 701 Giuseppe Alibrandi SECTION 8 VALIDATION 725 8.1 Analytical Method Validation: Principles and Practices 727 Chung Chow Chan 8.2 Analytical Method Validation and Quality Assurance 743 Isabel Taverniers, Erik Van Bockstaele, and Marc De Loose 8.3 Validation of Laboratory Instruments 791 Herman Lam 8.4 Pharmaceutical Manufacturing Validation Principles 811 E. B. Souto T. Vasconcelos D. C. Ferreira, and B. Sarmento INDEX 839
Rezensionen
This book is a valuable reference .The book contains everything you need to ensure full compliance and superior quality control. ( Pharmaceutical Technology Magazine , July 2, 2008)
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