Validation of On-line Total Organic Carbon Analysers for Release Testing Using ICH Q2

As the pharmaceutical industry seeks to reduce the number and associated costs of quality control laboratory tests, reliance on results from on-line TOC analysers for product release is becoming more attractive. The International Conference on Harmonisation (ICH) is an expert working group with representation from the United States2, European3, and Japanese4 Pharmacopoeias. In their harmonised tripartite guideline ICH Q21, Validation Of Analytical Procedures, they outline characteristics for consideration during the validation of analytical procedures included as part of registration applications submitted within the EC, Japan and USA.

This paper discusses how these characteristics may be applied to on-line Total Organic Carbon (TOC) analysers to enable them to be used to provide release test data for Water for Injection (WFI) and Purified Water (PW).

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