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[null,"1.","Record Nr.",null,"UNINA9910566699803321"]
[null,null,"Autore",null,"Huynh-Ba Kim"]
[null,null,"Titolo",null,"Analytical chemistry : an introduction to pharmaceutical GMP laboratory / / Kim Huynh-Ba"]
[null,null,"Pubbl/distr/stampa",null,"Hoboken, New Jersey : , : Wiley, , [2022]"]
[{"$nulls":4},"©2022"]
[null,null,"ISBN",null,"1-119-68047-6"]
[{"$nulls":4},"1-119-68046-8"]
[null,null,"Descrizione fisica",null,"1 online resource (419 pages)"]
[null,null,"Disciplina",null,"615.19"]
[null,null,"Soggetti",null,"Pharmaceutical industry - Quality control"]
[{"$nulls":4},"Analytical chemistry"]
[{"$nulls":4},"Drugs - Testing"]
[{"$nulls":4},"Electronic books."]
[null,null,"Lingua di pubblicazione",null,"Inglese"]
[null,null,"Formato",null,"Materiale a stampa"]
[null,null,null,"Livello bibliografico","Monografia"]
[null,null,null,"Nota di bibliografia","Includes bibliographical references and index."]
[null,null,"Nota di contenuto",null,"Cover -- Title Page -- Copyright Page -- Contents -- Einstein Quotation -- Preface -- About the Editor -- Biographies of Contributing Authors -- Editorial Notes -- Acknowledgments -- Chapter 1 Drug Regulations and the Pharmaceutical Laboratories -- 1.1 Introduction -- 1.2 Food and Drug Administration: Roles and Its Regulations -- 1.2.1 Code of Federation Regulations -- 1.2.2 FDA Guidance Documents -- 1.2.3 FDA Manual of Policies and Procedures -- 1.3 International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and Its Role -- 1.3.1 ICH Background -- 1.3.2 ICH Structure -- 1.3.3 ICH Organization -- 1.3.4 ICH Topics -- 1.4 Pharmaceutical Analysis -- 1.4.1 Analytical Testing -- 1.4.2 Interaction of the Analytical Development Department and Other Functional Areas -- 1.4.3 Drug Development Process -- 1.5 Summary -- List of Abbreviations -- References -- Chapter 2 Good Manufacturing Practices (GMPs) and the Quality Systems -- 2.1 Introduction to Good Manufacturing Practices -- 2.2 Objectives of GMPs -- 2.2.1 Definitions -- 2.2.2 Organization of 21 CFR Regulations -- 2.3 Personnel Qualification and Responsibilities - Subpart B -- 2.3.1 Responsibilities of the Quality Control Unit -- 2.3.2 Personnel Qualifications and Responsibilities -- 2.4 Equipment - Subpart D -- 2.4.1 Metrology Functions -- 2.4.2 Qualification Phases -- 2.5 "]
[{"$nulls":4},"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."]
[{"$nulls":4},"3.2.1 Raw Data and Analytical Data -- 3.2.2 Analyses -- 3.2.3 Analytical Documents -- 3.3 Basic Laboratory Procedures -- 3.3.1 Balances -- 3.3.2 Volumetric Glassware -- 3.3.3 Potentiometry (Ion-Selective Electrode) and pH Test -- 3.3.4 The Density Test -- 3.3.5 The Friability Test -- 3.3.6 The Hardness Test -- 3.3.7 The Titration Test -- 3.3.8 The Karl Fischer Titration-Water Determination -- 3.3.9 Loss on Drying -- 3.3.10 Residue on Ignition/Sulfated Ash -- 3.3.11 Thermo Gravimetric Analysis -- 3.3.12 Differential Scanning Calorimetry -- 3.3.13 The Disintegration Test -- 3.3.14 Particulate Matter -- 3.3.15 Osmolality -- 3.4 Chromatography -- 3.4.1 High-Performance Liquid Chromatography -- 3.4.2 Ultra-High-Pressure Liquid Chromatography -- 3.4.3 Detectors of Liquid Chromatography -- 3.4.4 System Suitability Tests for Chromatographic Methods -- 3.4.5 Maintenance of HPLC and UHPLC -- 3.4.6 Gas Chromatography -- 3.4.7 Thin-Layer Chromatography -- 3.4.8 Bio-Pharmaceutical Separations -- 3.5 Spectroscopic Sciences -- 3.5.1 Ultraviolet-Visible -- 3.5.2 Infrared-Absorption -- 3.5.3 Mass Spectroscopy -- 3.5.4 Atomic Absorption, Inductively Coupled Plasma, Inductively Coupled Plasma/Mass Spectrometry, and Inductively Coupled Plasma/Optical Emission Spectrometry -- 3.5.5 Nuclear Magnetic Resonance Spectroscopy -- 3.5.6 X-ray Absorption and X-ray Emission Spectrometry -- 3.6 Uniformity of Dosage Units -- 3.6.1 Weight Variation -- 3.6.2 Acceptance Criteria per USP &lt -- 905&gt --  -- 3.7 Elemental Analysis -- 3.8 Appearance -- 3.9 Visual Inspection -- 3.10 Microbiological Testing -- 3.10.1 Microbial Limits -- 3.10.2 Sterility -- 3.10.3 Bacterial Endotoxins -- 3.10.4 Antimicrobial Effectiveness Testing -- 3.11 Summary -- References -- Chapter 4 Control Strategies for Pharmaceutical Development -- 4.1 Introduction -- 4.2 Quality-by-Design Concept."]
[{"$nulls":4},"4.3 Risk Management -- 4.3.1 Risk Assessment -- 4.3.2 Risk Control -- 4.4 Establishing Specifications -- 4.4.1 What Is the Specification? -- 4.4.2 Typical Tests Included in the Specification of a Small Molecule Drug -- 4.4.3 Typical Tests Included in the Specification of Biological Drugs -- 4.4.4 Considerations of Setting Acceptance Criteria -- 4.5 Design of Experiments -- 4.5.1 Common Terms -- 4.5.2 Conducting the Study -- 4.5.3 Results Interpretation -- 4.5.4 Summary -- 4.6 Common Statistical Analysis -- 4.6.1 Mean, Standard Deviation (SD), and Relative Standard Deviation (RSD) -- 4.6.2 Confidence Interval -- 4.6.3 Statistical Significance (t-Test) -- 4.6.4 Outlier Detection -- 4.7 Summary -- List of Abbreviations -- References -- Chapter 5 Development and Validation of Analytical Procedures -- 5.1 Introduction -- 5.2 Method Development -- 5.2.1 Development of Physical, Chemical, and Microbiological Procedures -- 5.3 Qualification, Validation, and Verification -- 5.3.1 Qualification -- 5.3.2 Validation -- 5.3.3 Verification -- 5.3.4 Frequency of Study -- 5.4 Validation Parameters -- 5.4.1 Accuracy -- 5.4.2 Precision -- 5.4.3 Specificity -- 5.4.4 Quantitation and Detection Limits (QL and DL) -- 5.4.5 Linearity -- 5.4.6 Range -- 5.4.7 Robustness -- 5.4.8 System Suitability Tests (SST) -- 5.4.9 Stability of Samples During Analysis -- 5.4.10 Tie the Pieces Together -- 5.5 Validation for Physical, Chemical, "]
[{"$nulls":4},"Biotechnological, and Microbiological Procedures -- 5.6 Validation of In-process, Environmental, Release, and Stability Procedures -- 5.6.1 In-process Procedures -- 5.6.2 Environmental Procedures -- 5.6.3 Release and Stability Procedures -- 5.7 Other Procedures -- 5.7.1 Process Analytical Technology (PAT) -- 5.7.2 Parametric Release and Real-time Release -- 5.8 Validation of Procedures in Continuous and Batch Manufacturing -- 5.9 Summary."]
[{"$nulls":4},"List of Abbreviations -- References -- Chapter 6 Transfer of Analytical Procedures -- 6.1 Introduction -- 6.2 Purpose of Method Transfer -- 6.3 Transfer Options -- 6.3.1 Method Transfer Plan -- 6.3.2 Comparative Testing -- 6.3.3 Co-validation -- 6.3.4 Extended Validation or Partial Validation -- 6.3.5 Transfer Waiver -- 6.4 Method Transfer Process -- 6.4.1 Preparation Phase -- 6.4.2 Gap Analysis -- 6.4.3 Method Training Phase -- 6.4.4 Method Qualification Phase -- 6.5 Transfer Protocol -- 6.5.1 Content of a Transfer Protocol -- 6.5.2 Objectives/Scope -- 6.5.3 Roles and Responsibilities -- 6.5.4 Assessment of Receiving Lab -- 6.5.5 Materials, Facilities, and Instrumentation -- 6.5.6 Analyst Training -- 6.5.7 Qualification Procedure -- 6.5.8 Acceptance Criteria -- 6.5.9 Protocol Amendment and Deviation -- 6.6 Method Transfer Report -- 6.6.1 Objectives -- 6.6.2 Data Evaluation -- 6.6.3 Conclusion of Transfer Report -- 6.6.4 Analytical Transfer File -- 6.7 Related Documents -- 6.8 Handling Transfer Failures -- 6.9 Transfer to a Contract Lab -- 6.10 Transfer to an International Site -- 6.11 Summary -- References -- Chapter 7 Dissolution Testing in the Pharmaceutical Laboratory -- 7.1 Introduction -- 7.2 Regulatory and Compendial Role in Dissolution Testing -- 7.3 Theory -- 7.4 Equipment Operation and Sources of Error -- 7.4.1 Equipment Variables -- 7.4.2 Media Deaeration -- 7.4.3 Vibration -- 7.4.4 Water Bath of Dissolution Equipment -- 7.4.5 Glass Vessels -- 7.5 Common Errors of Dissolution Apparatus -- 7.5.1 USP Apparatus 1 and 2 -- 7.5.2 USP Apparatus 3 -- 7.5.3 USP Apparatus 4 -- 7.5.4 USP Apparatus 5 -- 7.5.5 USP Apparatus 6 -- 7.5.6 USP Apparatus 7 -- 7.6 Dissolution Method Considerations -- 7.6.1 Sample Introduction -- 7.6.2 Media Attributes -- 7.6.3 Observations -- 7.6.4 Sinkers -- 7.6.5 Filters -- 7.6.6 Manual Sampling."]
[{"$nulls":4},"7.6.7 Automation of Dissolution Sampling -- 7.6.8 Cleaning of Dissolution Equipment -- 7.7 Method Development -- 7.7.1 Drug Properties -- 7.7.2 Dosage Form Properties -- 7.7.3 Dissolution Profile -- 7.7.4 Dissolution Media -- 7.7.5 Medium Volume -- 7.7.6 Deaeration -- 7.7.7 Speed -- 7.7.8 Sinkers -- 7.7.9 Filtration -- 7.7.10 Time Points - Immediate Release -- 7.7.11 Fast Stir or Infinity Point -- 7.7.12 Time Points for Extended-Release Products -- 7.8 Poorly Soluble Drugs -- 7.8.1 Sink Conditions -- 7.8.2 Apparatus Selection -- 7.8.3 The Discriminatory Power of the Method -- 7.9 Setting Specifications -- 7.10 Harmonization -- 7.11 Method Validation -- 7.12 Validation of Product Performance Parameters -- 7.12.1 Accuracy/Recovery -- 7.12.2 Selectivity -- 7.12.3 Solution Stability -- 7.12.4 Filter -- 7.12.5 Robustness -- 7.12.6 Intermediate Precision -- 7.12.7 Automated Methodology -- 7.13 Validation of the Analytical Finish -- 7.14 Method Transfer Considerations -- 7.14.1 Robustness -- 7.14.2 Details of the Analytical Method -- 7.14.3 Other Considerations -- 7.15 Good Manufacturing Practices (GMP) in the Dissolution Testing Laboratory -- 7.15.1 Metrology -- 7.15.2 Notebook Documentation -- 7.15.3 Equipment Qualification, Validation, and Method Critical Factors -- 7.15.4 Good Manufacturing Practice Audits -- 7.15.5 Training -- 7.16 Summary -- Acknowledgment -- List of Abbreviations -- Chapter 8 Analytical Data and the Documentation System -- 8.1 Introduction -- 8.1.1 Types "]
[{"$nulls":4},"of Documents -- 8.2 GMP for Records and Reports-Subpart J -- 8.2.1 General Requirements -- 8.2.2 Equipment Cleaning and Use Log -- 8.2.3 Component, Drug Product Container, Closure, and Labeling Records -- 8.2.4 Master Production and Control Records -- 8.2.5 Batch Production and Control Records -- 8.2.6 Production Record Review -- 8.2.7 Laboratory Records -- 8.3 Keeping Good Records."]
[{"$nulls":4},"8.3.1 Writing Good Procedures."]