api starting material
- Guideline or reference source
- ECA GAMP5 Approach and Risk Management
- EUGMP annex16
- ICHQ7 Good manufacturing practice for active pharmaceutical ingredients
- Definition
- A raw material, intermediate, or an API that is used in the production of an API and that is incorporated as a significant structural fragment into the structure of the API. An API Starting Material can be an article of commerce, a material purchased from one or more suppliers under contract or commercial agreement, or produced in-house. API Starting Materials are normally of defined chemical properties and structure.
- Broader Term
- starting material
- Related Term
- API
- intermediate
- raw material
- starting material for drug substance
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