Huber Validation and Qualification in Analytical Laboratories

2. Auflage 2013
ISBN: 978-0-8493-8268-0
Verlag: Taylor & Francis
Format: PDF
Kopierschutz: Adobe DRM (»Systemvoraussetzungen)

E-Book, Englisch, 288 Seiten

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

Laboratory managers and analytical scientists in the pharmaceutical industry and testing laboratories; quality assurance managers and personnel; consultants, corporate training departments and reference librarians.

Autoren/Hrsg.

Huber, Ludwig

Fachgebiete

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