Glossary

Active Pharmaceutical Ingredient (API) / Drug Substance

A substance or mixture of substances used in manufacturing a medicine that becomes the active ingredient in the finished product.

Related sections

ICH Q7 Glossary ICH Q7 §§7–11

Related terms

Active Ingredient626 casesAPI Starting Material1 casesDrug Product / Medicinal Product5,943 cases

Real inspection findings

Findings from regulators' inspection documents in which this term appears.

  1. Failure to prepare, review, and approve documents related to the manufacturing of API in accordance with written procedures.
    FDA · FDA Warning Letter · 2024-12-17
  2. You failed to conduct adequate identity testing on incoming components, including APIs, used in the manufacture of your drug products.
    FDA · FDA Warning Letter · 2025-10-07
  3. Several API lots were released into production without performing adequate acceptance testing…
    FDA · FDA Warning Letter · 2022-08-30
See 85 findings that mention this term

Source

ICH Q7, Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients, §20 Glossary, Active Pharmaceutical Ingredient
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