Carboxyl terminal analysis
Freedy, James [OBI] (Jfreedy@obius.jnj.com)
Mon, 17 Aug 1998 07:38:29 -0400
Greetings ABRF,
I would like to know the current status of carboxyl terminal
analysis, performed under cGMP/GLP regulations? From my perspective, this
methodology seems tricky and most labs if performing the technique at all,
do not hold to the absolute rigors of cGMP/GLP. I know that these rigors can
be a matter of interpretation, but what I really mean is, have these labs
successfully managed an FDA inspection without being sited? Thanks in
advance. I would also be very interested in anyone's opinion who performs
carboxyl terminal analysis routinely as to the "tricky" nature of the
technique.
Sincerely,
James G. Freedy
Scientist
Ortho Biotech, A J&J Co.
Raritan, New Jersey
jFreedy@OBIUS.JNJ.com