| Description |
1 online resource (419 p.) |
| Contents |
Cover -- Title Page -- Copyright Page -- Contents -- Einstein Quotation -- Preface -- About the Editor -- Biographies of Contributing Authors -- Editorial Notes -- Acknowledgments -- Chapter 1 Drug Regulations and the Pharmaceutical Laboratories -- 1.1 Introduction -- 1.2 Food and Drug Administration: Roles and Its Regulations -- 1.2.1 Code of Federation Regulations -- 1.2.2 FDA Guidance Documents -- 1.2.3 FDA Manual of Policies and Procedures -- 1.3 International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and Its Role -- 1.3.1 ICH Background |
|
1.3.2 ICH Structure -- 1.3.3 ICH Organization -- 1.3.4 ICH Topics -- 1.4 Pharmaceutical Analysis -- 1.4.1 Analytical Testing -- 1.4.2 Interaction of the Analytical Development Department and Other Functional Areas -- 1.4.3 Drug Development Process -- 1.5 Summary -- List of Abbreviations -- References -- Chapter 2 Good Manufacturing Practices (GMPs) and the Quality Systems -- 2.1 Introduction to Good Manufacturing Practices -- 2.2 Objectives of GMPs -- 2.2.1 Definitions -- 2.2.2 Organization of 21 CFR Regulations -- 2.3 Personnel Qualification and Responsibilities - Subpart B |
|
2.3.1 Responsibilities of the Quality Control Unit -- 2.3.2 Personnel Qualifications and Responsibilities -- 2.4 Equipment - Subpart D -- 2.4.1 Metrology Functions -- 2.4.2 Qualification Phases -- 2.5 Laboratory Controls -- 2.5.1 General Requirements -- 2.5.2 Testing and Release for Distribution -- 2.5.3 Stability Program -- 2.5.4 Retention Program -- 2.6 Records and Reports -- 2.7 Pharmaceutical Quality -- 2.7.1 Quality Manual -- 2.7.2 Quality Risk Management -- 2.7.3 Product Quality Review -- 2.7.4 Pharmaceutical Quality Systems -- List of Abbreviations -- References |
|
Chapter 3 Analytical Techniques Used in the GMP Laboratory -- 3.1 Introduction -- 3.2 Definitions -- 3.2.1 Raw Data and Analytical Data -- 3.2.2 Analyses -- 3.2.3 Analytical Documents -- 3.3 Basic Laboratory Procedures -- 3.3.1 Balances -- 3.3.2 Volumetric Glassware -- 3.3.3 Potentiometry (Ion-Selective Electrode) and pH Test -- 3.3.4 The Density Test -- 3.3.5 The Friability Test -- 3.3.6 The Hardness Test -- 3.3.7 The Titration Test -- 3.3.8 The Karl Fischer Titration-Water Determination -- 3.3.9 Loss on Drying -- 3.3.10 Residue on Ignition/Sulfated Ash -- 3.3.11 Thermo Gravimetric Analysis |
|
3.3.12 Differential Scanning Calorimetry -- 3.3.13 The Disintegration Test -- 3.3.14 Particulate Matter -- 3.3.15 Osmolality -- 3.4 Chromatography -- 3.4.1 High-Performance Liquid Chromatography -- 3.4.2 Ultra-High-Pressure Liquid Chromatography -- 3.4.3 Detectors of Liquid Chromatography -- 3.4.4 System Suitability Tests for Chromatographic Methods -- 3.4.5 Maintenance of HPLC and UHPLC -- 3.4.6 Gas Chromatography -- 3.4.7 Thin-Layer Chromatography -- 3.4.8 Bio-Pharmaceutical Separations -- 3.5 Spectroscopic Sciences -- 3.5.1 Ultraviolet-Visible -- 3.5.2 Infrared-Absorption |
| Notes |
Description based upon print version of record |
|
3.5.3 Mass Spectroscopy |
| Form |
Electronic book
|
| ISBN |
9781119680468 |
|
1119680468 |
|
