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

Published Hoboken, N.J. : Wiley, 2013

Click on the following:
ProQuest Ebook Central

Copies

Description 1 online resource (xvii, 393 pages, 12 unnumbered pages of plates) : color illustrations Series Wiley series in biotechnology and bioengineering Wiley Series in Biotechnology and Bioengineering Wiley series in biotechnology and bioengineering. 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 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 Pharmaceutical and Biopharmaceutical Manufacturing features contributions from leading international experts in risk management and drug manufacturing. These contributions reflect the latest research, practices, and industry standards as well as the authors' firsthand experience. Readers can turn to the book for: basic foundation of risk management principles, practices, and applications. Tested and proven tools and methods for managing risk in pharmaceutical and biopharmaceutical product manufacturing processes. Recent FDA guidelines, EU regulations, and international standards governing the application of risk management to drug manufacturing. Case studies and detailed examples demonstrating the use and results of applying risk management principles to drug product manufacturing. Bibliography and extensive references leading to the literature and helpful resources in the field With its unique focus on the application of risk management to biopharmaceutical and pharmaceutical manufacturing, this book is an essential resource for pharmaceutical and process engineers as well as safety and compliance professionals involved in drug manufacturing Bibliography Includes bibliographical references and index Subject Pharmaceutical industry -- Risk management Risk management. Pharmaceutical technology. Pharmaceutical Preparations -- standards Risk Management Drug Industry -- organization & administration Technology, Pharmaceutical risk management. BUSINESS & ECONOMICS -- Industries -- Pharmaceutical & Biotechnology. Pharmaceutical technology Risk management Form Electronic book Author Mollah, A. Hamid Long, Mike Baseman, Harold S LC no. 2012045117 ISBN 9781118514375 1118514378 9780470552346 0470552344 1118514343 9781118514344 1118514394 9781118514399

  Permalink