This message was posted by a user wishing to remain anonymous
Hello Reg Community,
I was hoping you could tell me when a QDA is required if I only manufacture once a year? A specific scenario: if I manufacture stability lots of final, finished items as part of the design and development process, i.e., not for commercial distribution, do I need to do a QDA in the quarter following that cGMP manufacturing?
Any guidance is helpful. Thank you in advance for your time and expertise.
Respectfully,
Anon