Pharma Bioanalytical Lab

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 documentationTemplates and SOP outlines for daily lab operationsTools for deviation management, CAPAs, and analytical risk assessmentsRegulatory insights from FDA, EMA, WHO, and ICH M10 standardsVisual aids, glossary terms, and case studies that simplify complex conceptsWhether 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.