Table of Contents for Quality Risk Management in the FDA-Regulated Industry


List of Figures and Tables
xi
Acronyms xiii
Preface xv
Acknowledgments xix
Chapter 1 Introduction to Quality Risk Management
1(22)
1.1 What Is Quality Risk Management?
1(3)
1.2 Taste of Raspberries, Taste of Death: The 1937 Elixir Sulfanilamide Incident
4(6)
1.3 Seventy Years Later
10(1)
1.4 Risk-Based Approach
11(3)
FDA's Strategic Action Plan
13(1)
Risk-Based Model for Inspectional Oversight
13(1)
Part 11 Guidance
13(1)
Aseptic Processing Guidance
13(1)
1.5 More Than Safety Risks: From Safety Risks to Quality by Design (QbD)
14(3)
Medication Guides
14(1)
Quality by Design
15(1)
Design Controls for Medical Devices
16(1)
1.6 ISO 31000
17(2)
1.7 Historical Perspective and Current Situation
19(4)
Chapter 2 Current Initiatives
23(28)
2.1 FDA-Wide
23(2)
2.2 Drugs and Biotechnology Products
25(8)
2.2.1 ICH Q9
25(1)
2.2.2 QbD Guidances
26(5)
2.2.3 REMS and Medication Guides
31(2)
2.3 Medical Devices
33(10)
2.3.1 ISO 14971:2007
33(2)
2.3.2 GHTF Guidelines
35(4)
2.3.3 Non-U.S. Regulations
39(4)
2.4 Food Safety: ISO 22000:2005 and Hazard Analysis and Critical Control Points (HACCP)
43(2)
2.5 Supply Chain: Risk Consideration for Regulated Products
45(6)
Chapter 3 Principles of Quality Risk Management
51(10)
3.1 Principles of Quality Risk Management
51(4)
Continual Improvement
54(1)
Full Accountability for Risks
54(1)
Application of Risk Management in All Decision Making
54(1)
Continual Communications
55(1)
Full Integration in the Organization's Governance Structure
55(1)
3.2 Science and Risk-Based Approach to Product Quality
55(3)
3.3 Quality Systems Approach
58(3)
Chapter 4 General Quality Risk Management Process
61(22)
4.1 Introduction to Quality Risk Management Process
61(2)
4.2 Responsibilities and Initiation of the Risk Management Process
63(2)
4.3 Risk Assessment
65(10)
4.3.1 Risk Identification
65(2)
4.3.2 Risk Analysis
67(6)
4.3.3 Risk Evaluation
73(2)
4.4 Risk Control
75(2)
4.4.1 Risk Reduction
76(1)
4.4.2 Risk Acceptance
77(1)
4.5 Risk Documentation and Communication
77(1)
4.6 Risk Monitoring and Effectiveness Review
78(1)
4.7 Application of Risk Assessment During Life Cycle Phases
79(1)
4.8 Enhanced Risk Management
80(3)
Continual Improvement
81(1)
Full Accountability for Risks
81(1)
Application of Risk Management in All Decision Making
81(1)
Continual Communications
81(1)
Full Integration in the Organization's Governance Structure
82(1)
Chapter 5 Integration of Risk Management with Quality Management
83(24)
5.1 Risk Management Plans
83(5)
5.1.1 Scope of the Plan
84(1)
5.1.2 Assignment of Responsibilities and Authorities
85(1)
5.1.3 Requirements for Review of Risk Management Activities
85(1)
5.1.4 Criteria for Risk Acceptability
85(1)
5.1.5 Verification Activities
85(1)
5.1.6 Methods of Obtaining Relevant Post-Production Information
86(1)
5.1.7 Example of Risk Management Plan Applied to Medication Guides
86(2)
5.2 Risk-Based CAPA System
88(6)
5.3 Examples of Integration between Risk Management and other Quality Management Tools
94(13)
5.3.1 The Process Analytical Technology (PAT) Approach
94(5)
5.3.2 Risk-Based Inspection Site Selection
99(5)
5.3.3 The Quality System Inspection Technique (QSIT)
104(3)
Chapter 6 Methodologies and Tools
107(30)
6.1 Selection and Types of Risk Assessment Techniques
107(2)
6.1.1 Availability of Resources
108(1)
6.1.2 The Nature and Degree of Uncertainty
109(1)
6.1.3 Complexity
109(1)
6.2 Application of Risk Assessment During Life Cycle Phases
109(1)
6.3 Risk Assessment Techniques and Tools
110(27)
6.3.1 Basic Risk Management Facilitation Methods
110(4)
6.3.2 Failure Mode and Effects Analysis (FMEA)
114(4)
6.3.3 Fault Tree Analysis
118(4)
6.3.4 Hazard Analysis and Critical Control Points (HACCP)
122(5)
6.3.5 Hazard and Operability Analysis (HAZOP)
127(3)
6.3.6 Cause-and-Effect Analysis/5 Whys
130(1)
6.3.7.5 Whys
131(2)
6.3.8 Preliminary Hazard Analysis (PHA)
133(1)
6.3.9 Risk Ranking and Filtering
134(2)
6.3.10 Supporting Statistical Tools
136(1)
Chapter 7 Practical Applications of Quality Risk Management to the Life Science Manufacturing Industry
137(28)
7.1 Management
137(15)
7.1.1 Internal Audit
138(1)
7.1.2 Training
138(2)
7.1.3 Regulatory Actions: Recalls and Health Hazard Evaluation
140(7)
7.1.4 CAPA System
147(1)
7.1.5 Supplier Selection and Control
148(2)
7.1.6 Outsourcing
150(2)
7.2 Documents and Records/Change Management
152(1)
7.3 Facilities and Equipment
153(1)
7.4 Design and Development
153(2)
7.5 Production and Process Control
155(8)
7.5.1 Trend Analysis and Statistical Process Control
156(1)
7.5.2 Aseptic Process in the Pharmaceutical Industry
157(1)
7.5.3 Validations and Revalidations
158(2)
7.5.4 Laboratory Control
160(1)
7.5.5 Packaging and Labeling
161(1)
7.5.6 Materials
162(1)
7.6 Servicing
163(2)
Appendix A General Examples 165(10)
Appendix B Case Studies 175(64)
Appendix C Fail-Safe FMEA 239(10)
Appendix D Useful Web Sites 249(2)
Glossary 251(4)
Bibliography 255(4)
Index 259