On the ANDA Refuse to File (RTF) checklist, Items 1 and 3 of CMC drug product section mentioned “pilot scale” in the definition about the size of representative batch. What does a pilot scale stand for?

刊登日期:2021-11-17  |  點閱次數 : 385 次 

According to Chapter 6 Glossary of “Guideline on Stability Testing of Drug Substances and Products”, a pilot scale is a batch of a drug product manufactured by a procedure fully representative of simulating that to be applied to a full production scale batch. For solid oral dosage forms, a pilot scale is generally, at a minimum, 100,000 dosage units or one-tenth that of production scale, whichever is larger. If the production scale is less than 100,000 dosage units, the actual production batch should be used as the representative batch.




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