Definition

The substance or mixture of substances used in the manufacture of a drug product that is intended to furnish pharmacological activity. Same as drug substance.

Example

The API is the therapeutically active component; it must be manufactured under GMP and meet agreed specifications.

Regulatory source

ICH Q7, 21 CFR 210.3(b)(7)

Common mistakes

Sourcing API from unqualified suppliers or without a DMF/ASMF where required.

Inspector question

How do you qualify and maintain approval of your API suppliers?

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