Meet the Expert: Method Validation in Pharmaceutical Analysis

Introduction

• A conversation with Joachim Ermer on Method Validation in Pharmaceutical Analysis: A Guide to Best Practice, now in its third edition. Joachim shares what motivated him to write it, how it’s structured, and why moving beyond a checklist mentality is the key to robust analytical validation.
• Drawing on decades of experience in pharmaceutical quality control and lifecycle management, Joachim explains how the book bridges the gap between ICH guidelines and real-world application, helping scientists connect validation data to what actually matters: routine use.
• Now running his own consultancy, Joachim brings a pragmatic, science-based perspective to validation, transfer, and statistics, shaped by years of working group contributions to ATP, ICH, and USP expert committees.

Key Learning Outcomes

• From checklist to science: The book challenges the tendency to treat ICH guidelines as a checklist, pushing instead for a performance-focused, purpose-driven approach to validation.
• Lifecycle at the core: Structured around the three stages of the analytical lifecycle, the book covers method design, performance qualification, and ongoing verification, alongside equipment qualification, data integrity, and the analytical target profile.
• Guidelines need interpretation: ICH Q2 and Q14 provide orientation, but the book helps practitioners interpret and adapt those requirements to their specific analytical procedures and intended use.
• Routine is everything: The most important takeaway, in Joachim’s own words, is to always look at the routine side of your procedure. Data that doesn’t reflect real routine application is, simply put, a waste of time.

About

Joachim Ermer studied biochemistry before entering the pharmaceutical industry in the 1990s. Over a career spanning Hoechst AG, Aventis, and Sanofi, he held roles in drug development analytics, global QC harmonisation, and QC lifecycle management. In 2020, he launched his own consultancy, focusing on validation, analytical transfer, and statistics. He has contributed to major working groups including the FPR Quality by Design and Lifecycle Management group and USP expert committees, and is the lead author of Method Validation in Pharmaceutical Analysis: A Guide to Best Practice, now in its third edition.