| As with all regulations, some are easier
to follow than others. There are always
going to be scenarios ‘at the margins’
where any regulation will struggle to
define the correct procedure or process
for dealing with a specific issue, or may
appear to be in conflict with some other
aspect of best practice.
This has been amply illustrated within the
laboratory sector in recent times, with the
delayed implementation of General Chapter
<467> Residual Solvents of the United
States Pharmacopoeia – National Formulary
(USP-NF). This proposed revision to the
USP-NF had first been scheduled for
introduction on 1st January 2007, only for
implementation to be delayed until 1st July
2007, and then further delayed with an
implementation date of 1st July 2008.
BACKGROUND TO CHAPTER <467>
The essential rationale behind USP <467>
is an attempt to harmonise test standards
for residual solvents for medicines sold
in the US in accordance with a model
already adopted by the European
Pharmacopeia. It aims to prescribe
standard test methods for three classes
of solvent. These are:
- Class 1 solvents, a defined list of
chemicals that are known or suspected
to be human carcinogens
- Class 2 solvents, a defined list known
to be animal carcinogens or to exhibit
other toxicity
- Class 3 solvents, a defined list of
chemicals having low toxic potential
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