Ludwig Huber

Validation and Qualification in Analytical Laboratories

• Gebundenes Buch

Produktbeschreibung

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.

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Produktdetails

• Verlag: CRC Press
• 2. Auflage
• Seitenzahl: 314
• Erscheinungstermin: 23. Juli 2007
• Englisch
• Abmessung: 235mm x 157mm x 21mm
• Gewicht: 608g
• ISBN-13: 9780849382673
• ISBN-10: 084938267X
• Artikelnr.: 22888920

Autorenporträt

Ludwig Huber

Inhaltsangabe

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