bulk process intermediate
- Guideline or reference source
- HCGMP Canada GMP guidelines 2009
- Definition
- Any intermediate form of a Schedule C or D drug (e.g., final bulk intermediate, bulk material, bulk concentrate, drug substance) which must undergo further processing before it becomes a final product. They are usually characterized by a holding time, storage conditions and the application of in-process tests.
- Broader Term
- intermediate
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