in-house primary reference material
- Guideline or reference source
- ICHQ6B Test procedures and acceptance criteria for biotechnological/biological products
- Definition
- An appropriately characterized material prepared by the manufacturer from a representative lot(s) for the purpose of biological assay and physicochemical testing of subsequent lots, and against which in-house working reference material is calibrated.
- Broader Term
- reference material
- Related Term
- in-house working reference material
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