Method Development in the EU

Introduction to Method Development

As a hard and fast rule, all analytical procedures in a pharmaceutical testing environment must follow a clear, easy to follow procedure that has been shown to be effective and applicable to the analyte in question, able to reliably and consistently produce the desired results. 

Method development is a key process in the pharmaceutical industry that encompasses the process of establishing chemical analytical techniques to: 

• Identify and/or quantify impurities, target molecules, residual solvents and degradants; 
• Ensure critical quality parameters through quality control;  
• Assess purity and potency of manufactured products.