Method Development in the EU

by: Alex Xuereb, QA/PV Specialist @Quintian Pharma

 

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. 
Banner web-Method  development  in the EU

Analytical methods are usually applied to: 

Method development made easy?

To get more information or support, get in touch with our RA Team or check our Regulatory Affairs dedicate page to find the most suitable solution for your company.

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