ABSTRACT
Analytical procedures are used throughout drug development, manufacturing, and release of drug substances and drug products. Therefore, accuracy and reliability of analytical results are crucial for ensuring quality, safety, and efficacy of pharmaceuticals. Accordingly, the process to confirm that a method is suitable for its intended purpose, known as analytical validation, has been in the regulatory focus for a long time. The International Conference on Harmonization defined the validation process to ensure consistency in worldwide regulatory expectations. This entry interprets these ICH regulatory definitions and requirements, as well as provides direction towards rational and efficient validation.
