The submission ANDA batches can have a smaller size than the established
pilot scale, according to the ICH definition, when any one of the following
circumstances prevails:
• The reference listed drug product has an orphan drug designation.
• Use of a controlled drug substance is based on a Drug Enforcement
Administration allocation.
• The test batch size is the same as the commercial batch size with the
commitment that a prior approval supplement (PAS) will be provided
when there is a scale-up.
