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Risk management applications in pharmaceutical and biopharmaceutical manufacturing

Author: A Hamid Mollah; Mike Long; Harold S Baseman
Publisher: Hoboken, N.J. : Wiley, 2013.
Series: Wiley series in biotechnology and bioengineering.
Edition/Format:   eBook : Document : EnglishView all editions and formats
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  Read more...
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Genre/Form: Electronic books
Additional Physical Format: Print version:
(OCoLC)726822927
Material Type: Document, Internet resource
Document Type: Internet Resource, Computer File
All Authors / Contributors: A Hamid Mollah; Mike Long; Harold S Baseman
ISBN: 9781118514375 1118514378 9780470552346 0470552344
OCLC Number: 828743774
Description: 1 online resource (xvii, 393 pages, [12] pages of plates) : color illustrations.
Contents: 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. 6.4 USE OF DESIGN OF EXPERIMENT (DOE) TO ELIMINATE AND STUDY (C)PPS AT LABORATORY SCALE.
Series Title: Wiley series in biotechnology and bioengineering.
Responsibility: edited by A. Hamid Mollah, Mike Long, Harold S. Baseman.

Abstract:

This book contains both the theory and practice of risk management (RM) and provides the background, tools, and application of risk in pharmaceutical and biologics manufacturing and operations. It  Read more...

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