Glossary

Intermediate

A material produced during processing of an API that must undergo further molecular change or purification before it becomes an API.

Related sections

ICH Q7 Glossary ICH Q7 §§7–11

Related terms

Active Pharmaceutical Ingredient (API) / Drug Substance85 casesAPI Starting Material1 casesIntermediate Product1 cases

Real inspection findings

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

  1. Your firm did not adequately prevent contamination of materials and intermediates.
    FDA · FDA Warning Letter · 2026-03-17
  2. Action taken/proposed by the NCA: Prohibition of supply The non-compliance affects all APIs and intermediates manufactured at the site.
    EMA · EU GMP NCR (EudraGMDP) · 2024-06-26
  3. Failure of your quality unit to exercise its responsibility to ensure the intermediates manufactured at your facility are in compliance with CGMP.
    FDA · FDA Warning Letter · 2025-03-11
See 109 findings that mention this term

Source

ICH Q7, §20 Glossary, Intermediate
← Browse the whole glossary