Risk management applications in pharmaceutical and biopharmaceutical manufacturing / edited by A. Hamid Mollah, Mike Long, Harold S. Baseman.

Format:

Book

Contributor:

Mollah, A. Hamid.

Long, Mike, 1968-

Baseman, Harold S.

Series:

Wiley Series in Biotechnology and Bioengineering

Wiley series in biotechnology and bioengineering

Language:

English

Subjects (All):

Pharmaceutical industry--Risk management.

Pharmaceutical industry.

Physical Description:

1 online resource (426 p.)

Edition:

1st ed.

Place of Publication:

Hoboken, N.J. : Wiley, 2013.

Summary:

Sets forth tested and proven risk management practices in drug manufacturing Risk management is essential for safe and efficient pharmaceutical and biopharmaceutical manufacturing, control, and distribution. With this book as their guide, readers involved in all facets of drug manufacturing have a single, expertly written, and organized resource to guide them through all facets of risk management and analysis. It sets forth a solid foundation in risk management concepts and then explains how these concepts are applied to drug manufacturing. Risk Management Applications in

Contents:

Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing; Contents; Preface; Contributors; About the Authors; 1 Background and Introduction; 1.1 RISK MANAGEMENT OF PHARMACEUTICAL AND BIOPHARMACEUTICAL MANUFACTURE; 1.2 A PRACTICAL GUIDE TO RISK MANAGEMENT; 1.2.1 Additional Points to Consider; 1.3 OVERVIEW OF THE BOOK; 1.4 FINAL THOUGHTS; REFERENCES; 2 Risk Management Tools; 2.1 APPLICABILITY; 2.2 RISK MANAGEMENT; 2.3 RISK MANAGEMENT PROCESS; 2.3.1 Risk Assessment; 2.3.2 Risk Control; 2.3.3 Risk Review/Communication; 2.4 RISK ANALYSIS/ASSESSMENT TOOLS

2.4.1 Preliminary Hazard Analysis (PHA)2.4.2 Failure Mode Effects Analysis (FMEA) and Failure Mode Effects and Criticality Analysis (FMECA); 2.4.3 Hazard and Operability Analysis (HAZOP); 2.4.4 Fault Tree Analysis (FTA); 2.4.5 Hazard Analysis and Critical Control Point (HACCP); 2.4.6 Risk Ranking and Filtering (RRF); 2.4.7 Other Risk Analysis Tools; 2.5 BASIC FACILITATION TOOLS; 2.5.1 Flowcharts; 2.5.2 Process Mapping; 2.5.3 Check Sheets; 2.5.4 Cause and Effect Diagrams (Fishbone or Ishikawa Diagram); 2.5.5 5 Why Analysis; 2.5.6 Histograms; 2.5.7 Pareto Analysis; 2.5.8 Control Charts

2.6 COMPARISON OF RISK ASSESSMENT TOOLS2.7 RESIDUAL RISK EVALUATION; 2.8 SOURCES OF RISK INFORMATION; 2.9 CONCLUSION; DEFINITIONS; ACKNOWLEDGMENT; REFERENCES; FURTHER READING; 3 Risk Management: Regulatory Expectation, Risk Perception, and Organizational Integration; 3.1 INTRODUCTION; 3.2 QRM REGULATORY EXPECTATIONS; 3.2.1 General System Expectations; 3.2.2 Establishing Risk Communication and Reporting Mechanisms; 3.2.3 Risk Registers; 3.2.4 Audit of the Risk Management Systems; 3.3 PROBLEMS OF SUBJECTIVITY AND UNCERTAINTY DURING QRM EXERCISES

3.3.1 Cognitive Operations When Assessing Risk: "This is Your Brain on Risk"3.3.2 Perception and Perspectivism; 3.3.3 Risk's Precautionary Principle; 3.3.4 Risk Regulation's Unintended Consequence: Asymmetry of Risk Knowledge; 3.4 INTEGRATION INTO ORGANIZATIONAL PROCESSES; 3.4.1 Training; 3.5 CONCLUSION; REFERENCES; 4 Statistical Topics and Analysis in Risk Assessment; 4.1 INTRODUCTION; 4.2 UNCERTAINTY; 4.3 LUCK AND PROBABILITY; 4.4 DEFINITIONS OF PROBABILITY; 4.5 RULES OF PROBABILITY; 4.6 CAUTIONS; 4.7 RISK; 4.7.1 Venn Diagram; 4.7.2 Conditional Probability; 4.8 STATISTICAL RISK

4.9 RARE EVENTS4.9.1 Calculating POISSON; 4.10 COINCIDENCES; 4.11 ESTIMATING PROBABILITIES; 4.12 CONCLUSION; REFERENCES; FURTHER READING; 5 Quality by Design; 5.1 BACKGROUND; 5.2 DEVELOPMENT OF PRODUCTS USING A QBD APPROACH; 5.3 MAIN STEPS FOR A QUALITY BY DESIGN APPROACH FOR A NEW PRODUCT; 5.4 EXAMPLES OF QBD APPROACHES; 5.5 CONCLUSION; GLOSSARY AND DEFINITIONS; REFERENCES; 6 Process Development and Clinical Product Manufacturing; 6.1 QUALITY VISION OF PHARMACEUTICAL DEVELOPMENT; 6.2 BASIS FOR DESIGN-TARGET PRODUCT PROFILE AND PRELIMINARY HAZARD ANALYSIS; 6.3 PRODUCT CONTROL STRATEGY

6.4 USE OF DESIGN OF EXPERIMENT (DOE) TO ELIMINATE AND STUDY (C)PPS AT LABORATORY SCALE

Notes:

Description based upon print version of record.

Includes bibliographical references and index.

ISBN:

9781118514344

1118514343

9781118514399

1118514394

9781283993784

1283993783

9781118514375

1118514378

OCLC:

827208436