QC Labs

QC Labs: A Practical Guide for Analytical Methods
Author: Mirela Gorjanu, MSc
Your blueprint for mastering pharmaceutical quality control.
In a world where regulatory scrutiny, data integrity, and patient safety define success, QC Labs: A Practical Guide for Analytical Methods is the trusted companion every pharmaceutical professional needs.
This comprehensive and deeply practical guide walks you through the full spectrum of quality control operations from foundational lab setup and instrument qualification to advanced method validation, risk-based decision-making, and regulatory inspection readiness. Whether you're a QC analyst, QA specialist, regulatory affairs professional, or laboratory manager, this book is your essential toolkit.
Inside, you'll find:
✔ Step-by-step instructions for HPLC, GC, spectroscopy, titration, and microbiological testing
✔ ICH, FDA, and EMA-compliant method validation frameworks
✔ Real-world case studies, audit checklists, and troubleshooting references
✔ Sample SOPs, data integrity principles, and ALCOA+ best practices
✔ Emerging technologies: LIMS, PAT, automation, AI, and real-time release strategies
Written in clear, accessible language by pharmaceutical chemist Mirela Gorjanu, this book bridges theory and execution, empowering professionals to meet the highest standards of compliance and lab excellence.