Pharma Bioanalytical Lab: A Practical Guideby 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.
