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Qdossier Qsauri
"A"

acceptance criteria
Guideline or reference source
ICHQ6A Specifications: new chemical drug substances and products
ICHQ6B Test procedures and acceptance criteria for biotechnological/biological products
ICHQ7 Good manufacturing practice for active pharmaceutical ingredients
Definition
Numerical limits, ranges or other suitable measures for acceptance of the results of analytical procedures which the drug substance or drug product or materials at other stages of their manufacture should meet.
Used For
acceptance criterion
Narrower Term
acceptance criteria for software
acceptance criteria for specimens
pre-determined acceptance criteria
shelf life acceptance criteria
Related Term
analytical procedure
specification
specification, release
 

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