Glossary

Intermediate

Further molecular change or purification Intermediate API
Illustration

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

Source · ICH Q7, §20 Glossary, Intermediate

Related sections

ICH Q7 Glossary ICH Q7 §§7–11

Related terms

Active Pharmaceutical Ingredient (API) / Drug Substance85 casesAPI Starting Material1 caseIntermediate Product1 case

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. Prohibition of supply Suspension of the distribution and sale of any active pharmaceutical ingredient or intermediate that has been manufactured, repackaged or relabelled in the facilities of OCB PHARMACEUTICAL, S.R.L.
    EMA · EU GMP NCR (EudraGMDP) · 2026-09-28
See 111 findings whose text contains this term

Counted as of 2026-09-24 — the search you land on shows today's figures, so it may differ slightly.

Source

ICH Q7, §20 Glossary, Intermediate

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