USP General Chapter <1226> Comes into Force on 1 December 2007

GMP News
1 August 2007

USP General Chapter Comes into Force on 1 December 2007

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.

This new USP General Chapter will be presented to you at the GMP Education Course "Quality Control of Raw Materials" to be held in Prague from 16-17 October 2007.

One of the focus topics of this education course is reduced testing of APIs and excipients. You will hear how you can reduce the scope of sampling and testing of incoming goods through a reliable supplier qualification programme and thus optimise the efficiency of your company's procedures for incoming goods control - while at the same time fulfilling all cGMP requirements.

Dr Günter Brendelberger
On behalf of the European Compliance Academy (ECA)

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