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Qdossier Qsauri
"A"

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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