Validating analytical methods is a critical aspect of the pharmaceutical industry, aimed to demonstrate the suitability, reliability, and consistency of analytical procedures applied to evaluate the quality of Active Pharmaceutical Ingredients (APIs) and medicinal products. This process plays a crucial role in the pharmaceutical industry by guaranteeing that APIs and medicines meet established quality standards and are safe for patients.
While analytical methods are necessary elements in upholding quality and ensuring consistency, they should be tailored to their purpose and backed by science. This underscores the critical need for guidelines like ICH Q14 and ICH Q2, which offer a structured approach to developing and validating suitable, accurate, and scientifically sound analytical methods applied for the quality check of drug substances and products and present a comprehensive framework to ensure these methods yield the desired results effectively