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Analytical chemistry : an introduction to pharmaceutical GMP laboratory / / Kim Huynh-Ba
| Analytical chemistry : an introduction to pharmaceutical GMP laboratory / / Kim Huynh-Ba |
| Autore | Huynh-Ba Kim |
| Pubbl/distr/stampa | Hoboken, New Jersey : , : Wiley, , [2022] |
| Descrizione fisica | 1 online resource (419 pages) |
| Disciplina | 615.19 |
| Soggetto topico |
Pharmaceutical industry - Quality control
Analytical chemistry Drugs - Testing |
| Soggetto genere / forma | Electronic books. |
| ISBN |
1-119-68047-6
1-119-68046-8 |
| Formato | Materiale a stampa  |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
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 -- 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 < -- 905> -- -- 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. 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, 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. 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. 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 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. 8.3.1 Writing Good Procedures. |
| Record Nr. | UNINA-9910566699803321 |
Huynh-Ba Kim
|
||
| Hoboken, New Jersey : , : Wiley, , [2022] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Analytical chemistry : an introduction to pharmaceutical GMP laboratory / / Kim Huynh-Ba
| Analytical chemistry : an introduction to pharmaceutical GMP laboratory / / Kim Huynh-Ba |
| Autore | Huynh-Ba Kim |
| Pubbl/distr/stampa | Hoboken, New Jersey : , : Wiley, , [2022] |
| Descrizione fisica | 1 online resource (419 pages) |
| Disciplina | 615.19 |
| Soggetto topico |
Pharmaceutical industry - Quality control
Analytical chemistry Drugs - Testing |
| ISBN |
1-119-68047-6
1-119-68046-8 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
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 -- 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 < -- 905> -- -- 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. 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, 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. 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. 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 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. 8.3.1 Writing Good Procedures. |
| Record Nr. | UNINA-9910830995003321 |
|
Huynh-Ba Kim
|
||
| Hoboken, New Jersey : , : Wiley, , [2022] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
The certified pharmaceutical GMP professional handbook. / / Mark Allen Durivage, editor
| The certified pharmaceutical GMP professional handbook. / / Mark Allen Durivage, editor |
| Edizione | [Second edition.] |
| Pubbl/distr/stampa | Milwaukee, Wisconsin : , : ASQ Quality Press, , 2016 |
| Descrizione fisica | 1 online resource (516 pages) : illustrations |
| Disciplina | 615.1/9 |
| Soggetto topico |
Drug development
Drugs - Standards Pharmaceutical industry - Quality control |
| Soggetto genere / forma | Electronic books. |
| ISBN | 1-951058-89-5 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Record Nr. | UNINA-9910467611103321 |
| Milwaukee, Wisconsin : , : ASQ Quality Press, , 2016 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
The certified pharmaceutical GMP professional handbook. / / Mark Allen Durivage, editor
| The certified pharmaceutical GMP professional handbook. / / Mark Allen Durivage, editor |
| Edizione | [Second edition.] |
| Pubbl/distr/stampa | Milwaukee, Wisconsin : , : ASQ Quality Press, , 2016 |
| Descrizione fisica | 1 online resource (516 pages) : illustrations |
| Disciplina | 615.1/9 |
| Soggetto topico |
Drug development
Drugs - Standards Pharmaceutical industry - Quality control |
| ISBN |
1-951058-90-9
1-951058-89-5 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Record Nr. | UNINA-9910794296003321 |
| Milwaukee, Wisconsin : , : ASQ Quality Press, , 2016 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
The certified pharmaceutical GMP professional handbook. / / Mark Allen Durivage, editor
| The certified pharmaceutical GMP professional handbook. / / Mark Allen Durivage, editor |
| Edizione | [Second edition.] |
| Pubbl/distr/stampa | Milwaukee, Wisconsin : , : ASQ Quality Press, , 2016 |
| Descrizione fisica | 1 online resource (516 pages) : illustrations |
| Disciplina | 615.1/9 |
| Soggetto topico |
Drug development
Drugs - Standards Pharmaceutical industry - Quality control |
| ISBN |
1-951058-90-9
1-951058-89-5 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Record Nr. | UNINA-9910813363003321 |
| Milwaukee, Wisconsin : , : ASQ Quality Press, , 2016 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Continuous processing in pharmaceutical manufacturing / / edited by Ganapathy Subramanian
| Continuous processing in pharmaceutical manufacturing / / edited by Ganapathy Subramanian |
| Pubbl/distr/stampa | Weinheim, Germany : , : Wiley-VCH Verlag GmbH & Co. KGaA, , 2015 |
| Descrizione fisica | 1 online resource (531 p.) |
| Disciplina | 338.4561615 |
| Soggetto topico |
Pharmaceutical industry - Quality control
Pharmaceutical industry - Research |
| ISBN |
3-527-67370-9
3-527-67368-7 3-527-67371-7 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
Continuous Processing in Pharmaceutical Manufacturing; Contents; List of Contributors; Preface; 1. Proteins Separation and Purification by Expanded Bed Adsorption and Simulated Moving Bed Technology; 1.1 Introduction; 1.2 Protein Capture by Expanded Bed Technology; 1.2.1 Adsorbent Materials; 1.2.2 Expanded Bed Adsorption/Desorption of Protein; 1.2.3 Modeling of the Expanded Bed; 1.3 Proteins Separation and Purification by Salt Gradient Ion Exchange SMB; 1.3.1 Adsorption Isotherms and Kinetics of BSA and Myoglobin on Ion Exchange Resins
1.3.2 Salt Gradient Formation and Process Design for IE-SMB Chromatography1.3.3 Separation Region of Salt Gradient IE-SMB Chromatography; 1.3.4 Proteins Separation and Purification in Salt Gradient IE-SMB with Open Loop Configuration; 1.4 Conclusion; References; 2. BioSMB Technology as an Enabler for a Fully Continuous Disposable Biomanufacturing Platform; 2.1 Introduction; 2.2 Integrated Continuous Bioprocessing; 2.3 Multicolumn Chromatography; 2.4 BioSMB Technology; 2.5 Fully Disposable Continuous Processing; 2.6 Case Studies; 2.7 Regulatory Aspects; 2.8 Conclusions; References 3. Impact of Continuous Processing Techniques on Biologics Supply Chains3.1 Introduction; 3.1.1 The Biologics Industry; 3.1.2 The Biologics Value Chain; 3.1.3 Downstream Purification Costs; 3.2 Chromatography Techniques Used in Downstream Purification of Biomolecules; 3.2.1 Need for Continuous Manufacturing in Downstream Purification; 3.2.2 The Multicolumn Countercurrent Solvent Gradient Purification Chromatography System; 3.3 Next-Generation Biologic Products - Bispecific Monoclonal Antibodies; 3.3.1 Major Biopharma Companies and Their Interest in Bispecific Mabs 3.3.2 Challenges in Purification of Bispecific Monoclonal Antibodies3.4 Improving the Downstream Processing of Bispecific Mabs by Introduction of MCSGP in the Value Chain; 3.4.1 Advantages of Utilizing MCSGP Process in Bispecific Mabs Purification as Compared to Batch Chromatography; 3.4.2 Impact of MCSGP System on Biologic Supply Chains; 3.4.3 Impact on Patent Approval Structure of Biologic Drugs; 3.4.3.1 For a Manufacturer Who Already has a Biologic Drug in the Market; 3.4.3.2 For a Manufacturer Who is Developing a Biologic Drug; 3.4.4 Impact on Big Biopharma Companies 3.4.5 Impact on the Chromatography Market3.4.6 Limitations of the MCSGP System; 3.5 Conclusion; 3.6 Further Research; Acknowledgments; 3.A Appendix/Additional Information; 3.A.1 Regulatory Structure for Bispecific Monoclonal Antibodies; 3.A.1.1 Regulatory Compliance Comparison between US, EU, and Emerging Economies; References; 4. Integrating Continuous and Single-Use Methods to Establish a New Downstream Processing Platform for Monoclonal Antibodies; 4.1 Introduction; 4.2 Harvest and Clarification; 4.2.1 The Challenge and Technology Selection; 4.2.1.1 Centrifugation; 4.2.1.2 Filtration 4.2.1.3 Impurity Precipitation |
| Record Nr. | UNINA-9910140481503321 |
| Weinheim, Germany : , : Wiley-VCH Verlag GmbH & Co. KGaA, , 2015 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Countering the problem of falsified and substandard drugs / / Committee on Understanding the Global Public Health Implications of Substandard, Falsified, and Counterfeit Medical Products, Board on Global Health ; Gillian J. Buckley and Lawrence O. Gostin, editors ; Institute of Medicine of the National Academies
| Countering the problem of falsified and substandard drugs / / Committee on Understanding the Global Public Health Implications of Substandard, Falsified, and Counterfeit Medical Products, Board on Global Health ; Gillian J. Buckley and Lawrence O. Gostin, editors ; Institute of Medicine of the National Academies |
| Pubbl/distr/stampa | Washington, District of Columbia : , : National Academies Press, , [2013] |
| Descrizione fisica | 1 online resource (375 p.) |
| Disciplina | 364.1668 |
| Soggetto topico |
Pharmaceutical industry - Quality control
Fraud - Prevention |
| Soggetto genere / forma | Electronic books. |
| ISBN | 0-309-26940-7 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | ""Front Matter""; ""Reviewers""; ""Acknowledgments""; ""Acronyms and Abbreviations""; ""Contents""; ""Boxes, Figures, and Tables""; ""Summary""; ""1 Introduction""; ""2 The Effects of Falsified and Substandard Drugs""; ""3 The Magnitude of the Problem""; ""4 Causes of Falsified and Substandard Drugs""; ""5 Weaknesses in the Drug Distribution Chain""; ""6 Detection Technology""; ""7 An International Code of Practice for Falsified and Substandard Medicines""; ""Appendix A: Glossary""; ""Appendix B: Committee Biographies""; ""Appendix C: Meeting Agendas"" |
| Record Nr. | UNINA-9910464856303321 |
| Washington, District of Columbia : , : National Academies Press, , [2013] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Countering the problem of falsified and substandard drugs / / Committee on Understanding the Global Public Health Implications of Substandard, Falsified, and Counterfeit Medical Products, Board on Global Health ; Gillian J. Buckley and Lawrence O. Gostin, editors ; Institute of Medicine of the National Academies
| Countering the problem of falsified and substandard drugs / / Committee on Understanding the Global Public Health Implications of Substandard, Falsified, and Counterfeit Medical Products, Board on Global Health ; Gillian J. Buckley and Lawrence O. Gostin, editors ; Institute of Medicine of the National Academies |
| Pubbl/distr/stampa | Washington, District of Columbia : , : National Academies Press, , [2013] |
| Descrizione fisica | 1 online resource (375 p.) |
| Disciplina | 364.1668 |
| Soggetto topico |
Pharmaceutical industry - Quality control
Fraud - Prevention |
| ISBN | 0-309-26940-7 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | ""Front Matter""; ""Reviewers""; ""Acknowledgments""; ""Acronyms and Abbreviations""; ""Contents""; ""Boxes, Figures, and Tables""; ""Summary""; ""1 Introduction""; ""2 The Effects of Falsified and Substandard Drugs""; ""3 The Magnitude of the Problem""; ""4 Causes of Falsified and Substandard Drugs""; ""5 Weaknesses in the Drug Distribution Chain""; ""6 Detection Technology""; ""7 An International Code of Practice for Falsified and Substandard Medicines""; ""Appendix A: Glossary""; ""Appendix B: Committee Biographies""; ""Appendix C: Meeting Agendas"" |
| Record Nr. | UNINA-9910789364703321 |
| Washington, District of Columbia : , : National Academies Press, , [2013] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Countering the problem of falsified and substandard drugs / / Committee on Understanding the Global Public Health Implications of Substandard, Falsified, and Counterfeit Medical Products, Board on Global Health ; Gillian J. Buckley and Lawrence O. Gostin, editors ; Institute of Medicine of the National Academies
| Countering the problem of falsified and substandard drugs / / Committee on Understanding the Global Public Health Implications of Substandard, Falsified, and Counterfeit Medical Products, Board on Global Health ; Gillian J. Buckley and Lawrence O. Gostin, editors ; Institute of Medicine of the National Academies |
| Pubbl/distr/stampa | Washington, District of Columbia : , : National Academies Press, , [2013] |
| Descrizione fisica | 1 online resource (375 p.) |
| Disciplina | 364.1668 |
| Soggetto topico |
Pharmaceutical industry - Quality control
Fraud - Prevention |
| ISBN | 0-309-26940-7 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | ""Front Matter""; ""Reviewers""; ""Acknowledgments""; ""Acronyms and Abbreviations""; ""Contents""; ""Boxes, Figures, and Tables""; ""Summary""; ""1 Introduction""; ""2 The Effects of Falsified and Substandard Drugs""; ""3 The Magnitude of the Problem""; ""4 Causes of Falsified and Substandard Drugs""; ""5 Weaknesses in the Drug Distribution Chain""; ""6 Detection Technology""; ""7 An International Code of Practice for Falsified and Substandard Medicines""; ""Appendix A: Glossary""; ""Appendix B: Committee Biographies""; ""Appendix C: Meeting Agendas"" |
| Record Nr. | UNINA-9910819676503321 |
| Washington, District of Columbia : , : National Academies Press, , [2013] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Global approach in safety testing : ICH guidelines explained
| Global approach in safety testing : ICH guidelines explained |
| Edizione | [1st ed. 2013.] |
| Pubbl/distr/stampa | New York, : Springer, 2012 |
| Descrizione fisica | 1 online resource (320 p.) |
| Disciplina | 615.190218 |
| Altri autori (Persone) |
van der LaanJan Willem
DeGeorgeJoseph J |
| Collana | AAPS Advances in the Pharmaceutical Sciences Series |
| Soggetto topico |
Pharmaceutical industry - Quality control
Drugs - Law and legislation Drugs - Testing - Standards Pharmaceutical technology - Standards |
| ISBN |
1-299-33560-8
1-4614-5950-8 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | The International Conference on Harmonisation. History of Safety Guidelines -- EU Perspective on ICH -- The Value and Benefits of the International Conference on Harmonisation (ICH) to Drug Regulatory Authorities Advancing Harmonization for Better Public Health -- A Japanese Perspective on Implementation of the Three Rs: Incorporating Best Scientific Practices into Regulatory Process -- Towards more Scientific Relevance in Carcinogenicity Testing -- The Evolution, Scientific Reasoning and Use of ICH S2 Guidelines for Genotoxicity Testing of Pharmaceuticals -- Toxicokinetics: A Guidance for Assessing Systemic Exposure in Toxicology Studies , Where are we now; an S3A/S3B update (1995-2011) -- Duration of Acute and Chronic Toxicity Testing in Animals (ICH S4A and S4B) -- Why and how did Reproduction Toxicity Testing make its early entry into and Rapid Success in ICH? -- ICH S6 Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals -- Safety Pharmacology: Guidelines S7A and S7B -- ICH S8: History and Perspectives -- ICH S9: Nonclinical Evaluation of Anticancer Pharmaceuticals a Perspective from Regulators on the Development of the Guideline -- Non-Clinical Safety Studies for the Conduct of Human Clinical Trials for Pharmaceuticals ICH M3 and M3(R2). |
| Record Nr. | UNINA-9910437852303321 |
| New York, : Springer, 2012 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
