Pharma Bioanalytical Lab: A Practical Guide: 5 - Brossura

Gorjanu, Mirela

Brossura

ISBN 13: 9798284788868

Casa editrice: Independently published, 2025

Riassunto

Pharma Bioanalytical Lab: A Practical Guide
by Mirela Gorjanu
In the high-stake world of pharmaceutical development, data integrity isn’t optional; it’s critical. Pharma Bioanalytical Lab: A Practical Guide is the definitive handbook for scientists, analysts, and quality professionals working in regulated bioanalytical environments. Whether you're managing GLP-compliant studies, preparing for regulatory audits, or validating LC-MS/MS methods, this guide delivers practical, real-world strategies to ensure accuracy, compliance, and efficiency.
Written by experienced pharma chemist Mirela Gorjanu, this resource bridges theory and execution with:

• Step-by-step instructions for method development, validation, and documentation
• Templates and SOP outlines for daily lab operations
• Tools for deviation management, CAPAs, and analytical risk assessments
• Regulatory insights from FDA, EMA, WHO, and ICH M10 standards
• Visual aids, glossary terms, and case studies that simplify complex concepts

Whether you're setting up a new lab or optimizing an established one, this guide will help you build systems that are not just audit-ready but inspection-proof.

Dettagli dell'edizione

• Editore: Independently published
• Data di pubblicazione: 2025
• Lingua: Inglese
• ISBN 13: 9798284788868
• Rilegatura: Copertina flessibile
• Numero di pagine: 100
• Contatto del produttore: non disponibile
• Persona responsabile: non disponibile