Analytical chemistry : an introduction to pharmaceutical GMP laboratory /: an introduction to pharmaceutical GMP laboratory. (2022)
- Record Type:
- Book
- Title:
- Analytical chemistry : an introduction to pharmaceutical GMP laboratory /: an introduction to pharmaceutical GMP laboratory. (2022)
- Main Title:
- Analytical chemistry : an introduction to pharmaceutical GMP laboratory
- Further Information:
- Note: Kim Huynh-Ba.
- Authors:
- Huynh-Ba, Kim
- Contents:
- Dedication ((Einstein quotation)) Preface About the Editor Biographies of Contributing Authors Editorial Notes Dedication Acknowledgments Chapter 1 – Drug Regulations and the Pharmaceutical Laboratories 1.1 Introduction 1.2 Food and Drug Administration: Role and its Regulations 1.2.1 Code of Federal 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 1.3.3.1 Steering Committee 1.3.3.2 Global Cooperation Group 1.3.3.3 MedDRA Management Board 1.3.3.4 Working Groups 1.3.3.5 Secretariat 1.3.3.6 Coordinators 1.3.4 ICH Topics 1.4 Pharmaceutical Analysis 1.4.1 Analytical Testing 1.4.2 Interaction Between the Analytical Development Department and Other Functional Areas 1.4.3 Drug Development Process 1.4.3.1 Toxicological Phase 1.4.3.2 Investigational New Drug 1.4.3.3 Clinical Phase 1.4.3.4 Registration Phase 1.4.3.5 New Drug Application 1.4.3.6 Post-Approval Phase References List of Abbreviations 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 Qualifications and Responsibilities – Subpart B 2.3.1 Responsibilities of Quality Control Unit 2.3.2 Personnel Qualifications and Responsibilities 2.4Dedication ((Einstein quotation)) Preface About the Editor Biographies of Contributing Authors Editorial Notes Dedication Acknowledgments Chapter 1 – Drug Regulations and the Pharmaceutical Laboratories 1.1 Introduction 1.2 Food and Drug Administration: Role and its Regulations 1.2.1 Code of Federal 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 1.3.3.1 Steering Committee 1.3.3.2 Global Cooperation Group 1.3.3.3 MedDRA Management Board 1.3.3.4 Working Groups 1.3.3.5 Secretariat 1.3.3.6 Coordinators 1.3.4 ICH Topics 1.4 Pharmaceutical Analysis 1.4.1 Analytical Testing 1.4.2 Interaction Between the Analytical Development Department and Other Functional Areas 1.4.3 Drug Development Process 1.4.3.1 Toxicological Phase 1.4.3.2 Investigational New Drug 1.4.3.3 Clinical Phase 1.4.3.4 Registration Phase 1.4.3.5 New Drug Application 1.4.3.6 Post-Approval Phase References List of Abbreviations 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 Qualifications and Responsibilities – Subpart B 2.3.1 Responsibilities of 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 – Subpart I 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 References List of Abbreviations 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 Thermal 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 3.4.1.1 Normal Phase Separation Mode 3.4.1.2 Reversed-Phase Separation Mode 3.4.1.3 Other HPLC Separation Modes 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 3.4.6.1 Residual Solvents 3.4.6.2 Hyphenated Technologies 3.4.7 Thin Layer Chromatography 3.4.8 Bio-Pharmaceutical Separations 3.4.8.1 Capillary Zone Electrophoresis 3.4.8.2 Isoelectric focusing 3.4.8.3 Sodium dodecyl sulfate-Polyacrylamide Gel electrophoresis (SDS-Page) 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 Endotoxin 3.10.4 Antimicrobial Effectiveness Testing 3.11 Summary References List of Abbreviations 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 4.3.1.1. Risk identification 4.3.1.2. Risk assessment 4.3.2. Risk Control 4.4 Establishing Specifications 4.4.1. What is specification? 4.4.2. Typical tests included in the specification of a small molecule drug 4.4.1. Drug substance 4.4.2. Drug product 4.4.3. Typical tests included in the specification of biological drugs 4.4.3.1. Drug substance 4.4.3.2. Drug product 4.4.4. Considerations of setting acceptance criteria 4.4.4.1. Process capability 4.4.4.2. Impact of drug substance to drug product specification 4.4.4.3. Release vs. shelf life 4.5 Design of Experiments (DoE) 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 References Chapter 5 – Development and Validation of Analytical Procedures 5.1 Introduction 5.2 Method Development 5.2.1 Physical, Chemical, and Microbiological Procedures</p&g … (more)
- Publisher Details:
- Hoboken, NJ : John Wiley & Sons, Inc
- Publication Date:
- 2022
- Copyright Date:
- 2022
- Extent:
- 1 online resource (xxx, 386 pages), illustrations
- Subjects:
- 615/.19
Pharmaceutical industry -- Quality control
Analytical chemistry
Drugs -- Testing
Drug development
Pharmaceutical chemistry
Chemistry, Pharmaceutical
Industrie pharmaceutique -- Qualité -- Contrôle
Chimie analytique
Médicaments -- Essais cliniques
Médicaments -- Développement
Chimie pharmaceutique
chemical analysis
Analytical chemistry
Drug development
Drugs -- Testing
Pharmaceutical industry -- Quality control
Electronic books - Languages:
- English
- ISBNs:
- 9781119680437
1119680433
9781119680468
1119680468
9781119680475
1119680476 - Related ISBNs:
- 9781119120919
- Notes:
- Note: Includes bibliographical references and index.
Note: Description based on online resource; title from digital title page (viewed on May 02, 2022). - Access Rights:
- Legal Deposit; Only available on premises controlled by the deposit library and to one user at any one time; The Legal Deposit Libraries (Non-Print Works) Regulations (UK).
- Access Usage:
- Restricted: Printing from this resource is governed by The Legal Deposit Libraries (Non-Print Works) Regulations (UK) and UK copyright law currently in force.
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- Available online (eLD content is only available in our Reading Rooms) ↗
- Physical Locations:
- British Library HMNTS - ELD.DS.688335
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- 12_013.xml