Risk management applications in pharmaceutical and biopharmaceutical manufacturing /

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...

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Detalles Bibliográficos
Clasificación:Libro Electrónico
Otros Autores: Mollah, A. Hamid, Long, Mike, Baseman, Harold S.
Formato: Electrónico eBook
Idioma:Inglés
Publicado: Hoboken, N.J. : Wiley, 2013.
Colección:Wiley series in biotechnology and bioengineering.
Temas:
Pharmaceutical industry > Risk management.
Risk management.
Pharmaceutical technology.
Pharmaceutical Preparations > standards
Risk Management
Drug Industry > organization & administration
Technology, Pharmaceutical
Industrie pharmaceutique > Gestion du risque.
Gestion du risque.
Techniques pharmaceutiques.
risk management.
BUSINESS & ECONOMICS > Industries > Pharmaceutical & Biotechnology.
Pharmaceutical technology
Risk management
Acceso en línea:Texto completo
Tabla de Contenidos:
  • 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.

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