Laboratory Quality Handbook of Best Practices and Relevant Regulations.

Detalles Bibliográficos
Clasificación:Libro Electrónico
Autor principal: Singer, Donald C.
Formato: Electrónico eBook
Idioma:Inglés
Publicado: Milwaukee : ASQ Quality Press, 2000.
Temas:
Laboratories > Quality control > Handbooks, manuals, etc.
Laboratories > Law and legislation > Handbooks, manuals, etc.
Laboratoires > Qualité > Contrôle > Guides, manuels, etc.
Laboratories > Law and legislation
Laboratories > Quality control
Handbooks and manuals
Acceso en línea:Texto completo
Tabla de Contenidos:
  • Dedication
  • Table of Contents
  • Preface
  • Acknowledgements
  • I. Quality in the Laboratory
  • 1 Quality Assurance in the Laboratory
  • 2 History of Regulation and the Laboratory
  • 3 An Overview of Key Parameters for Evaluating a Laboratory
  • II. Critical Laboratory Operations
  • 4 Training in the Laboratory
  • 5 Laboratory Documentation and Data
  • 6 Sample Control and LIM Systems
  • Appendix A EPA Good Automated Laboratory Practices
  • 7 Laboratory Equipment Qualification
  • 8 Equipment Calibration and Maintenance
  • 9 Laboratory Water and Water Purification Systems.
  • 10 Methods Validation
  • Appendix B ICH Guidelines on Validation of Analytical Procedures
  • 11 Out-of-Specification Results
  • III. Inspections
  • 12 An FDA Approach to Laboratory Inspections
  • Appendix D FDA Guide to Inspections of Pharmaceutical Quality Control Laboratories
  • Appendix E FDA Guide to Inspections of Microbiological Quality Control Laboratories
  • IV. An International Perspective
  • 13 Accreditation and Harmonization
  • Part V Additional Appendices
  • Appendix F The OECD Principles of Good Laboratory Practice.
  • Appendix G FDA Good Laboratory Practices for Nonclinical Lab Studies
  • Bibliography
  • Index.

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