Quality

2nd Edition - July 14, 2022
Authors: Kathleen E. McCormick, Janet H. Sanders
Language: English
Paperback ISBN:
9 7 8 - 0 - 3 2 3 - 9 0 8 1 5 - 3
eBook ISBN:
9 7 8 - 0 - 3 2 3 - 9 9 4 6 0 - 6

Quality, second edition, provides comprehensive application of regulatory guidelines and quality concepts and methodologies related to pharmaceutical manufacturing. It is an excell… Read more

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Quality, second edition, provides comprehensive application of regulatory guidelines and quality concepts and methodologies related to pharmaceutical manufacturing. It is an excellent resource for practitioners, those pursuing pharmaceutical related certifications, and for students trying to learn more about pharmaceutical manufacturing. This book provides the background theory, applied descriptions of the guidelines and concepts, plus questions and problems at the end of the chapters that will help provide practice for the reader to apply the concepts.
In this book the authors share their combined 60+ years of extensive practical experience in the industry and in process improvement combined with detailed understanding of the needs of the industry and education system. This book provides real-life examples from industry and guidelines for practical application of tools that can be referenced by operators, engineers, and management.
This book is fully revised, updated, and expanded with new content in areas such as QbD, Lean, Six Sigma, basic data analysis, and CAPA tools.

Cover image
Title page
Table of Contents
Copyright
Acknowledgments
Abbreviations
Chapter 1. Product life cycle
Abstract
1.1 Introduction
1.2 The drug development process
1.3 Preclinical studies
1.4 Clinical studies
1.5 Emergency use authorization
1.6 New drug registration process
1.7 Good laboratory practice
1.8 Good clinical practice
1.9 Pharmacovigilance
1.10 History of drug regulation in the United States
1.11 Unlicensed medicines
1.12 Good manufacturing practice
1.13 Good distribution practice
1.14 Chapter summary
1.15 Questions/problems
Further reading
Chapter 2. Good manufacturing practice
Abstract
2.1 Introduction
2.2 Definition of good manufacturing practice
2.3 Different versions of good manufacturing practice
2.4 Comparisons of different good manufacturing practice guidelines
2.5 Rules versus guidelines
2.6 Application of good manufacturing practice
2.7 Good manufacturing practice and manufacture of clinical trial material
2.8 Chapter summary
2.9 Questions/problems
Further reading
Chapter 3. Elements of quality management
Abstract
3.1 Introduction
3.2 The quality management system
3.3 Relationship between quality management, quality assurance, good manufacturing practice, and quality control
3.4 Documentation cascade
3.5 International guidelines
3.6 ICH Q10 expanded
3.7 Definitions of quality management
3.8 Definition of quality assurance
3.9 Responsibilities of quality assurance
3.10 Definition of quality control
3.11 Responsibilities of quality control
3.12 Quality management in Japan
3.13 Quality management in Canada
3.14 Chapter summary
3.15 Questions/problems
Further reading
Chapter 4. Quality systems and international standards
Abstract
4.1 Introduction
4.2 International Organization for Standardization
4.3 History of ISO 9000 series
4.4 Quality management principles
4.5 Quality system documentation
4.6 ISO 9001: 2015
4.7 Application of ISO 9000 standards to the pharmaceutical industry
4.8 ISO 14000 series
4.9 Chapter summary
4.10 Questions/problems
Further reading
Chapter 5. The management of quality
Abstract
5.1 Introduction
5.2 Evolution of the quality function
5.3 Alternative models for management of quality
5.4 Management of quality in a multinational company
5.5 The role of the quality manager
5.6 Responsibility for batch release
5.7 The equivalent role in the United States
5.8 Other parts of the world
5.9 Chapter summary
5.10 Questions/problems
Further reading
Chapter 6. Inspections and auditing
Abstract
6.1 Introduction
6.2 Types of inspections
6.3 Mutual recognition of inspections
6.4 Guidance on participating in inspections
6.5 GMP certification in the developing world
6.6 Case studies
6.7 Chapter summary
6.8 Questions/problems
References
Chapter 7. Quality improvement programs
Abstract
7.1 Introduction
7.2 Key figures in the history of quality
7.3 Prerequisites for successful quality improvement programs
7.4 Cost of quality
7.5 Calculating the cost of poor quality
7.6 Lean techniques
7.7 Six sigma methodology
7.8 Quality by design
7.9 Benchmarking
7.10 Summary
7.11 Questions/problems
References
Further reading
Chapter 8. Corrective and preventive action
Abstract
8.1 Introduction
8.2 Overview of corrective and preventive action
8.3 Implementing corrective action and preventive action
8.4 Quality tools and techniques
8.5 Chapter summary
8.6 Questions/problems
References
Further reading
Chapter 9. Calibration
Abstract
9.1 Introduction
9.2 Objectives of calibration
9.3 Calibration program
9.4 Calibration documentation
9.5 Instrument tagging
9.6 Carrying out calibration
9.7 Review of data
9.8 Different types of standards
9.9 Different types of calibration equipment
9.10 Maintenance of calibration equipment
9.11 Categorization of instrumentation
9.12 Purchase of new instruments
9.13 Review of calibration program
9.14 Training of calibration technicians
9.15 Calibration in good manufacturing practice guidelines
9.16 Chapter summary
9.17 Questions/problems
Further reading
Chapter 10. Validation
Abstract
10.1 Introduction
10.2 Overview of validation
10.3 Definitions of validation
10.4 Definitions of qualification
10.5 Validation versus qualification
10.6 Process validation
10.7 Stages of process validation
10.8 Validation documentation
10.9 Chapter summary
10.10 Questions/problems
Further reading
Chapter 11. Technology transfer
Abstract
11.1 Introduction
11.2 Reasons for technology transfer
11.3 Choosing the receiving site
11.4 Evaluating the hardware and software issues
11.5 Validation and registration
11.6 The technology transfer guide
11.7 Planning for a successful technology transfer
11.8 Maintaining quality during a factory closure
11.9 Chapter summary
11.10 Questions/problems
Further reading
Chapter 12. Water for pharmaceutical use
Abstract
12.1 Introduction
12.2 Reference documentation
12.3 Grades of water
12.4 Design of water treatment systems
12.5 Water pretreatment methods
12.6 Preparation of purified water
12.7 Preparation of water for injection
12.8 Storage and distribution of process water
12.9 Storage and distribution of purified water
12.10 Storage and distribution of water for injection
12.11 Monitoring and maintenance of pharmaceutical water systems
12.12 Biofilm
12.13 Common problems and troubleshooting
12.14 Wastewater treatment
12.15 Chapter summary
12.16 Questions/problems
References
Further reading
Chapter 13. Pharmaceutical microbiology
Abstract
13.1 Introduction
13.2 Overview of microorganisms
13.3 The microbiology of raw materials
13.4 Nonsterile products
13.5 Sterile products
13.6 Sterile manufacturing
13.7 Risks of contamination and their control
13.8 Validation and environmental monitoring
13.9 Sterilization
13.10 Chapter summary
13.11 Questions/problems
Further reading
Chapter 14. Good distribution practice
Abstract
14.1 Introduction
14.2 National and regional good distribution practice guidelines
14.3 Comparison of good distribution practice guidelines
14.4 Principles of good distribution practice
14.5 Chapter summary
14.6 Questions/problems
Further reading
Index

Life Sciences

Physical Sciences & Engineering

Social Sciences & Humanities

Health

Quality

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Kathleen E. McCormick

Janet H. Sanders