Pharma Bioanalytical Lab: A Practical Guide (Paperback) (ISBN-13: 9798284788868)

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.

Author: Mirela Gorjanu
ISBN-13: 9798284788868
Publisher: Independently Published
Language: English
Published: 05/21/2025
Pages: 102
Format: Paperback
Weight: 0.32lbs
Size: 9.00h x 6.00w x 0.21d