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.
Author(s): Shayne Cox Gad
Series: Pharmaceutical Development Series
Edition: 1
Publisher: Wiley-Interscience
Year: 2008
Language: English
Pages: 856
PHARMACEUTICAL MANUFACTURING HANDBOOK Regulations and Quality......Page 4
CONTRIBUTORS......Page 8
CONTENTS......Page 12
PREFACE......Page 16
SECTION 1 GOOD MANUFACTURING PRACTICES (GMP) AND OTHER FDA GUIDELINES......Page 18
1.1 Good Manufacturing Practices (GMPs) and Related FDA Guidelines......Page 20
1.2 Enforcement of Current Good Manufacturing Practices......Page 62
1.3 Scale-Up and Postapproval Changes (SUPAC) Regulations......Page 84
1.4 GMP-Compliant Propagation of Human Multipotent Mesenchymal Stromal Cells......Page 114
SECTION 2 INTERNATIONAL REGULATIONS OF GOOD MANUFACTURING PRACTICES......Page 134
2.1 National GMP Regulations and Codes and International GMP Guides and Guildelines: Correspondences and Differences......Page 136
SECTION 3 QUALITY......Page 180
3.1 Analytical and Computational Methods and Examples for Designing and Controlling Total Quality Management Pharmaceutical Manufacturing Systems......Page 182
3.2 Role of Quality Systems and Audits in Phatmaceutical Manufacturing Environment......Page 218
3.3 Creating and Managing a Quality Management System......Page 256
3.4 Quality Process Improvement......Page 304
SECTION 4 PROCESS ANALYTICAL TECHNOLOGY (PAT)......Page 328
4.1 Case for Process Analytical Technology: Regulatory and Industrial Perspectives......Page 330
4.2 Process Analytical Technology......Page 370
4.3 Chemical Imaging and Chemometrics: Useful Tools for Process Analytical Technology......Page 428
SECTION 5 PERSONNEL......Page 450
5.1 Personnel Training in Pharmaceutical Manufacturing......Page 452
SECTION 6 CONTAMINATION AND CONTAMINATION CONTROL......Page 472
6.1 Origin of Contamination......Page 474
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 550
6.3 Microbiology of Nonsterile Pharmaceutical Manufacturing......Page 560
SECTION 7 DRUG STABILITY......Page 574
7.1 Stability and Shelf Life of Pharmaceutical Products......Page 576
7.2 Drug Stability......Page 600
7.3 Effect of Packaging on Stability of Drugs and Drug Products......Page 658
7.4 Pharmaceutical Product Stability......Page 704
7.5 Alternative Accelerated Methods for Studying Drug Stability: Variable-Parameter Kinetics......Page 718
SECTION 8 VALIDATION......Page 742
8.1 Analytical Method Validation: Principles and Practices......Page 744
8.2 Analytical Method Validation and Quality Assurance......Page 760
8.3 Validation of Laboratory Instruments......Page 808
8.4 Pharmaceutical Manufacturing Validation Principles......Page 828
INDEX......Page 856
