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"P"

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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