Ranjith,
There is a saying "if you do not have time to do it right, you will
have time to do it over"
The COA for the "ANDA batch (prepared in manufacturing site, pilot
scale, used for
stability testing and ANDA application)" must report cGMP activities.
So the testing must have been done under full cGMP conditions: for
example, validated methods, instruments qualified and used according
your SOP's, by trained analysts with their training documented in
their files, the data recorded and reported according to your SOP's,
all signed off by your QC and/or QA as required by your SOP's.
Frank Bales, Ph.D.
The GMP Discussion Group is sponsored by gmp review - see
http://www.pharmweb.net/gmp.html
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