Analytical chemistry : an introduction to pharmaceutical GMP laboratory

"Analytical testing in the pharmaceutical industry is necessary to establish drug quality based on science and regulatory compliance. It requires analysts to acquire a solid understanding of analytical chemistry and also a thorough appreciation of pharmaceutical regulatory requirements to addre...

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Bibliographic Details
Main Author Huynh-Ba, Kim (Author)
Format Electronic eBook
LanguageEnglish
Published Hoboken, NJ : John Wiley & Sons, Inc., 2022.
Subjects
Pharmaceutical industry > Quality control.
Analytical chemistry.
Drugs > Testing.
Drug development.
Pharmaceutical chemistry.
elektronické knihy
electronic books
Online AccessFull text
ISBN9781119680437
1119680433
1119680468
9781119680475
1119680476
9781119680468
9781119120919
Physical Description1 online resource (xxx, 386 pages) : illustrations

Cover

Table of 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
  • 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.
  • 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.

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