Validations & Verifications for Elemental Impurity Testing

Given the current and pending changes to the USP General Chapters <232><233>, there has been much discussion and activity with respect to validation – or verification – of testing methods, as method validation must be specific to the matrix and elemental impurities within a given product or ingredient.

SGS has conducted validations for hundreds of customers over the years and is able to tailor validation work to your specifics needs and/or matrices.

In the video below, Francine Walker, Technical Director for CSL, provides an overview of the validation/verification process.  It’s our hope that this will help clarify what is involved in typical validation work, and provide a framework for our customers, as they work to comply with the USP <232><233> requirements for Elemental Impurity testing. Click here to watch.


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