Question

Size of a pilot plant batch is:

• A. \(\frac {1}{10}\)^th of marketing batch
• B. \(\frac 15\)^th of production batch
• C. \(\frac {1}{5}\)^th of marketing batch
• D. \(\frac {1}{10}\)^th of production batch

Answer 1

The Correct Option is D

The correct option is (D): \(\frac {1}{10}\)^th of production batch.

Answer 2

The question asks for the standard minimum size fixed for a pilot batch, expressed as a fraction relative to the batch that will eventually be manufactured. Let's check each fraction and reference batch against the accepted scale-up rule.

1. \(\frac{1}{10}\)th of marketing batch: Pilot batch size is defined relative to the intended commercial production batch, not to a separately named marketing batch, since marketing batch is not the standard reference point used in scale-up guidelines.
2. \(\frac{1}{5}\)th of production batch: This fraction is larger than the accepted minimum. Regulatory scale-up guidance sets the floor at one tenth of the production batch, not one fifth, so this option overstates the required minimum pilot size.
3. \(\frac{1}{5}\)th of marketing batch: This combines both an incorrect fraction and an incorrect reference batch, compounding the errors described in the two options above.
4. \(\frac{1}{10}\)th of production batch: Pilot plant studies are meant to bridge lab-scale development and full commercial manufacture, so guidelines fix the minimum pilot batch size at one tenth of the eventual production batch, or ten thousand dosage units, whichever is larger, giving data that reliably predicts how the process will behave at full scale.

Only this combination uses both the correct fraction, one tenth, and the correct reference point, the production batch.

The correct answer is \(\frac{1}{10}\)th of production batch.