pilot scale batch
- Guideline or reference source
- ICHQ1A Stability testing of new drug substances and drug products
- Definition
- A batch of a drug substance or drug product manufactured by a procedure fully representative of and simulating that to be applied to a full production scale batch. For solid oral dosage forms, a pilot scale is generally, at a minimum, one-tenth that of a full production scale or 100,000 tablets or capsules, whichever is the larger.
- Broader Term
- batch
- Related Term
- commitment batches
- pilot scale plant
- production batch
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