The ANDA submission batch must be manufactured in the same facility as the commercial batch in GMP setting. Please refer to the below guidance for additional clarification.
https://www.fda.gov/files/drugs/published/ANDAs--Stability-Testing-of-Drug-Substances-and-Products--Questions-and-Answers.pdf
------------------------------
Mehul Govani RAC
Regulatory Affairs Manager
Bellerose NY
United States
------------------------------
Original Message:
Sent: 05-Jul-2023 01:45
From: SUJAN BOSE
Subject: Original ANDA submission batch requirements
Dear Experts,
Is ANDA submission batch need to manufacture in the same facility where proposed commercial batch going to manufacture? If yes, then both of them will be inspected as a part of PAI
Looking for your expert opinion and any guidance reference.
------------------------------
SUJAN BOSE
M. Pharm
------------------------------