Validation and Qualification in Analytical Laboratories
Seiten
2007
|
2nd edition
Crc Press Inc (Verlag)
978-0-8493-8267-3 (ISBN)
Crc Press Inc (Verlag)
978-0-8493-8267-3 (ISBN)
Validation and Qualification in Analytical Laboratories
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.
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.
Ludwig Huber
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
| Erscheint lt. Verlag | 23.7.2007 |
|---|---|
| Zusatzinfo | 37 Tables, black and white; 48 Illustrations, black and white |
| Verlagsort | Bosa Roca |
| Sprache | englisch |
| Maße | 156 x 234 mm |
| Gewicht | 544 g |
| Themenwelt | Medizin / Pharmazie ► Medizinische Fachgebiete ► Pharmakologie / Pharmakotherapie |
| Technik | |
| ISBN-10 | 0-8493-8267-X / 084938267X |
| ISBN-13 | 978-0-8493-8267-3 / 9780849382673 |
| Zustand | Neuware |
| Haben Sie eine Frage zum Produkt? |
Mehr entdecken
aus dem Bereich
aus dem Bereich
Arzneimittelverzeichnis für Deutschland (einschließlich …
Buch | Hardcover (2024)
Rote Liste Service GmbH (Verlag)
CHF 149,95
Englisch für Apotheker und PTAs
Buch | Spiralbindung (2024)
Kohlhammer (Verlag)
CHF 44,75
