With regards to Item 11 of CMC drug product section on the ANDA Refuse to File (RTF) checklist, if water is used as solvent in the manufacturing process of a drug product, and will not remain in the final drug product, is it required to provide water test results?

刊登日期：2021-11-17 | 點閱次數 : 485 次

Yes, the test results of solvents are required, even if they don’t remain in the final drug product. In principle, the test results of solvents, which are used in the manufacture of representative drug product batches, should be provided.

(中文版)

	On the ANDA Refuse to File (RTF) checklist, Item 3 of annex checklist 5 states “
	With regards to Items 6 and 12 of CMC drug product section on the ANDA Refuse to

返回前一頁

Drugs Medical Devices Consultation Services Health Technology Assessment International Cooperation

With regards to Item 11 of CMC drug product section on the ANDA Refuse to File (RTF) checklist, if water is used as solvent in the manufacturing process of a drug product, and will not remain in the final drug product, is it required to provide water test results?

Web design