ABSTRACT
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. (ICH Q7A)
In reality APIs are chemicals or biochemicals that are used to improve health, reduce pain, sustain life, or perform a medical diagnosis. These materials are produced by chemical or biochemical processes in non-contaminating equipment and/or systems. These chemicals or biochemicals are used to produce final dosage form pharmaceutical products such as tablets, capsules, sterile liquid-filled vials, sterile powder-filled vials, sterile fluid-filled bottles, therapeutic ointments and balms, etc. The quality and properties of APIs can have a significant impact on the successful manufacture of final dosage form pharmaceutical products; therefore, the creation and purification of these chemical entities is regulated by the Food and Drug Administration (FDA) and requires adherence to current Good Manufacturing Practices (cGMPs). Additionally, the manufacturing and purification processes for these materials must ensure that the API product is not contaminated or otherwise adulterated. Excipients, non-active chemicals, and non-active biochemicals are also used in the production of final dosage form drug products and thus their manufacture may also be regulated by the FDA and require adherence to cGMPs.
