Analytical Method Validation: 8 Key Parameters to Ensure Regulatory Compliance

• By: Staff Editor
• Date: November 21, 2014

Analytical methods play a key role in assuring that drug substances and drug products conform to their specifications. Analytical methods should be validated to ensure reliability, consistency and accuracy of analytical data. Method validation has been a requirement of FDA and international regulations and accreditation standards since many years. Inadequacies in the validation process can incite FDA Warning Letters.