ABSTRACT
Active Pharmaceutical Ingredient (API) (or Drug Substance)—Any substance or mixture of substances intended to be used in the manufacture of a drug (medicinal) product and that, when used in the production of a drug, becomes an active ingredient of the drug product. Such substances are intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure and function of the body. Authorized Person-The person recognized by the national regulatory authority as having the responsibility for ensuring that each batch of finished product has been manufactured, tested, and approved for release in compliance with the laws and regulations in force in that country.
