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The number of rules and regulations are growing in the pharmaceutical industry. When determining which regulatory requirements must be met for validating a specific measurement or analytical instrument, and which supporting guidance may be beneficial when considering specific instrumentation, a simple four-step approach is recommended. This covers the general regulatory requirements, parameter-specific regulatory requirements, non-regulatory sources and instrument selection itself.
Harmonization efforts are simplifying guidance from the FDA, EMA and other bodies. But does harmonization mean more measurement qualification is required than before? And how does instrument selection enable real-time water release?
This white paper brings clarity to regulatory requirements, with a specific example demonstrating a method for continuous Total Organic Carbon (TOC) monitoring of Pharmaceutical Waters. It also introduces the new 6000TOCi sensor from METTLER TOLEDO.
The 6000TOCi Sensor from METTLER TOLEDO Thornton represents the latest advance in continuous, on-line TOC measurement. The 6000TOCi benefits from more than a decade of METTLER TOLEDO's experience in TOC instrument design, and integrates new, advanced features to support real-time release of water. Fully compliant with all major global pharmacopeias, the 6000TOCi is the ideal solution for any application where reliability, ease of use, and real-time release and processcontrol are desired.
.png/_jcr_content/renditions/cq5dam.web.1280.1280.png "Konduktivitetssensor / resistivitetssensor")
.png/_jcr_content/renditions/cq5dam.web.1280.1280.png "pH-analysatorer och ORP-analysatorer")