Pharmaceutical Manufacturing Handbook Regulations and Quality

PHARMACEUTICAL MANUFACTURING HANDBOOK Regulations and Quality......Page 3
CONTRIBUTORS......Page 7
CONTENTS......Page 11
PREFACE......Page 15
SECTION 1 GOOD MANUFACTURING PRACTICES (GMP) AND OTHER FDA GUIDELINES......Page 17
1.1 Good Manufacturing Practices (GMPs) and Related FDA Guidelines......Page 19
1.2 Enforcement of Current Good Manufacturing Practices......Page 61
1.3 Scale-Up and Postapproval Changes (SUPAC) Regulations......Page 83
1.4 GMP-Compliant Propagation of Human Multipotent Mesenchymal Stromal Cells......Page 113
SECTION 2 INTERNATIONAL REGULATIONS OF GOOD MANUFACTURING PRACTICES......Page 133
2.1 National GMP Regulations and Codes and International GMP Guides and Guildelines: Correspondences and Differences......Page 135
SECTION 3 QUALITY......Page 179
3.1 Analytical and Computational Methods and Examples for Designing and Controlling Total Quality Management Pharmaceutical Manufacturing Systems......Page 181
3.2 Role of Quality Systems and Audits in Phatmaceutical Manufacturing Environment......Page 217
3.3 Creating and Managing a Quality Management System......Page 255
3.4 Quality Process Improvement......Page 303
SECTION 4 PROCESS ANALYTICAL TECHNOLOGY (PAT)......Page 327
4.1 Case for Process Analytical Technology: Regulatory and Industrial Perspectives......Page 329
4.2 Process Analytical Technology......Page 369
4.3 Chemical Imaging and Chemometrics: Useful Tools for Process Analytical Technology......Page 427
SECTION 5 PERSONNEL......Page 449
5.1 Personnel Training in Pharmaceutical Manufacturing......Page 451
SECTION 6 CONTAMINATION AND CONTAMINATION CONTROL......Page 471
6.1 Origin of Contamination......Page 473
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......Page 549
6.3 Microbiology of Nonsterile Pharmaceutical Manufacturing......Page 559
SECTION 7 DRUG STABILITY......Page 573
7.1 Stability and Shelf Life of Pharmaceutical Products......Page 575
7.2 Drug Stability......Page 599
7.3 Effect of Packaging on Stability of Drugs and Drug Products......Page 657
7.4 Pharmaceutical Product Stability......Page 703
7.5 Alternative Accelerated Methods for Studying Drug Stability: Variable-Parameter Kinetics......Page 717
SECTION 8 VALIDATION......Page 741
8.1 Analytical Method Validation: Principles and Practices......Page 743
8.2 Analytical Method Validation and Quality Assurance......Page 759
8.3 Validation of Laboratory Instruments......Page 807
8.4 Pharmaceutical Manufacturing Validation Principles......Page 827
INDEX......Page 855