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USP Elemental Impurities Validation

USP Elemental Impurities Validation

Overview of USP <233> Validation

As required by USP <233>, Galbraith Laboratories requires validation before using USP <233> in a new material.  This page describes the method validation process as it specifically relates to USP <233>.  For general information on our method validation services, please click here.

Proposal Acceptance

Every USP <233> validation begins with a proposal (quotation) for the project.  When the terms of it are accepted, the client is asked to submit the sample along with a PO.  Once provided, GLI will begin the project by conducting the method development experiments.

Method Development

Method development on USP <233> validations is generally limited to an ICP-MS Screen.  This gives our staff the chance to check for potential interferences in the sample and devise the digestion conditions for the sample.  Once the development experiments are done, Galbraith staff provide an informal update to the client on the results.

Procedure

Galbraith will create a custom procedure for every USP <233> validation.  The procedure is meant to supplement USP <233> by providing analysis details such as sample mass, digestion conditions, internal standards, etc.  This procedure must be approved by the Galbraith QA and the client prior to being considered effective.

Protocol

Galbraith will also create a method validation protocol.  This document will contain necessary details on the experiments that will be performed and details on the report.  Like the procedure, this document must be approved by Galbraith QA and the client before it is effective.

Validation

When the development work has been completed and the protocol and procedure are approved, Galbraith will begin the validation experiments.  The nature of the experiments depends on whether a limit or quantitative test was indicated.  The experiments will comply with cGMP requirements and all data is inspected by Galbraith's QA Unit.

Report

Once the validation experiments are completed, Galbraith staff will prepare a final validation report.  The results of all experiments are discussed in the final report.  The document must be reviewed and approved by the client before the validation is considered complete.  Once the validation is complete, Galbraith can provide routine testing of the product using USP <233>.