My take on this is a pragmatic one. R&D can produce the COA-provided
that the R&D lab is functioning under total cGMP and comes under a
proper QA supervision. Remember the ANDA batch may be for clinical
and therefore being given to humans! All biobatches, certainly in
Europe must be manufactured and released under cGMP. So if you are
certain that your R&D lab is totally compliant in all details then go
ahead. I wouldn't!
In particular I think that your last comment-trying to avoid stricter
QA on QC leads me to believe that you yourself believe that R&D is
less than strict.
Malcolm Ross
Generapharm-training and Consultancy.
The GMP Discussion Group is sponsored by gmp review - see
http://www.pharmweb.net/gmp.html
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