|
With the second supplement to USP 30 - NF 25 (2007), now the General
Chapter <1226> - "Verification of Compendial Methods", which had been
published for commenting some time ago, has finally been included in the
American pharmacopoeia.
The verification refers to compendial methods used for the
first time in an analytical laboratory. It provides evidence of the fact that
acceptable results are obtained with the employed personnel, the available
equipment and the reagents used. It is to be welcomed that the USP expressly
points out that this requirement does not apply to methods already
established in a laboratory.
By verifying compendial methods, the US-American cGMP
requirement laid down in 21 CFR 211.194(a)(2) is implemented, which says
that 'the suitability of all testing methods used shall be verified under actual conditions of use'.
Users of compendial methods do not have to validate them
completely when using these methods in their laboratory for the first time.
However, a documented proof of suitability under actual conditions of use on
site should be furnished.
During verification, several selected analytical validation
parameters are checked that provide meaningful relevant data. A complete
revalidation of the compendial method is not required! Two
examples of relevant validation parameters mentioned in the text are
specificity, e.g. proving specificity of chromatographic methods within the
framework of the system suitability test, or testing the detection- or
quantitation limit of impurities. It is also positive that
verification is not required for some simple tests, like loss on drying,
residue on ignition or the pH value, unless there are hints that the
compendial method might not be suitable for the product in question.
|
