Active Pharmaceutical Ingredients (API) in Pharma: Manufacturing, ICH Q7, GMP, Impurities & FDA/Health Canada
Published by: Pharma Quality System Editorial Team • Editorial basis: FDA/ICH Q7 and Q11, ICH Q6A and quality-system principles, FDA API CGMP enforcement, and Health Canada GUI-0104 and Drug Establishment Licence requirements DRUG SUBSTANCE • ICH Q7 • ICH Q11 • GMP • IMPURITIES • PROCESS CONTROL • RELEASE • SUPPLY CHAIN An active pharmaceutical ingredient is the substance that provides the intended pharmacological activity of a medicine. Its quality is built through controlled starting materials, process understanding, impurity control, suitable equipment, validated critical steps, laboratory testing, quality-unit oversight, documentation and lifecycle management. Quick answer Active pharmaceutical ingredients (APIs) , also called drug substances , are substances or mixtures intended for use in manufacturing a drug product and that become the active ingredient of that product. API manufacturing can involve chemical synth...