I agree with Malcolm that some companies manage to interpret GMP as
Great Mounds of Paper. The silly situation is reached where the
process holds up the smooth flow of paper.
However I'm not in complete agreement with the not having log books
for pH meters and balances.
If the procedure is to buffer (standardise) the pH meter daily and
not before each pH check there should be a record that this has been
carried out - a simple log book. If there is more than 1 pH meter in
the lab, noting which measurements has been carried out on which
meter can make life easy should there be a problem.
A similar argument can be made for balances.
Most importantly Keep it Simple and the information can be recorded
in a few seconds. All that is required is date and either
Standardisation (Daily Check) or Lot Number.
Alan Newbery
The GMP Discussion Group is sponsored by gmp review - see
http://www.pharmweb.net/gmp.html
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