Validation and Qualification in Analytical Laboratories

2. Auflage 2007
ISBN: 978-0-8493-8267-3
Verlag: CRC Press

Buch, Englisch, 314 Seiten, Format (B × H): 157 mm x 235 mm, Gewicht: 608 g

This Second Edition discusses ways to improve pharmaceutical product quality while achieving compliance with global regulatory standards.  With comprehensive step-by-step instructions, practical recommendations, standard operating procedures (SOPs), checklists, templates, and graphics for easy incorporation in a laboratory. This title serves as a complete source to the subject, and explains how to develop and implement a validation strategy for routine, non-routine, and standard analytical methods, covering the entire equipment, hardware, and software qualification process.  It also provides guidance on qualification of certified standards, in-house reference materials, and people qualification, as well as internal and third party laboratory audits and inspections.

Zielgruppe

Academic, Professional, and Professional Practice & Development

Autoren/Hrsg.

Huber, Ludwig

Fachgebiete

• Naturwissenschaften Chemie Chemie Allgemein Pharmazeutische Chemie, Medizinische Chemie
• Naturwissenschaften Chemie Analytische Chemie

Inhaltsverzeichnis

Regulations.  Terminology.  Risk Assessment.  Master and Project Planning.  Design Qualification.  Installation Qualification.  Operational Qualification.  Performance Qualification.  Software and Computers.  Validation.  Data Review.  Out-of-Specifications.  Certified Reference Standards.  People.  Proficiency Testing.  Audits.  Appendix A: Glossary.  Appendix B: Testing.  Appendix C:  SOP.  Appendix D: Books.  Appendix E: References

Über Autor(innen)

Ludwig Huber