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Articles

Sampling and Analytical Record

Chromatography Data System

R.C. McDowall is the principle of McDowall Consulting and director of R.D. McDowall Limited, and "Questions of Quality" column editor for LCGC Europe, Spectroscopy's sister magazine.

The calibration and qualification of analytical systems is a journey, not an event.

Are You Ready for a Life Cycle Approach for Analytical Instruments and Systems?

Two recent warning letters show that the US FDA is substantially increasing the amount of remediation work it requires for companies to correct data integrity noncompliance. That work can be very expensive—far exceeding the cost of ensuring compliance in the first place.

Do You Really Understand the Cost of Noncompliance?

The California Department of Public Health has proposed to establish the first regulatory limit in the United States for hexavalent chromium (chromium-6) in drinking water. The proposed Maximum Contaminant Level (MCL) sets the limit for hexavalent chromium at 10 parts per billion. California, like those of other states and United States federal government, currently only regulates total chromium levels.

First Regulatory Limit for Hexavalent Chromium in Drinking Water Awaited in California

This article covers the changes so far to United States Pharmacopeia (USP) chapters <232> and <233>, the International Conference on Harmonisation (ICH), the European Medicines Agency (EMA), and the European Pharmacopoeia (EP), impending changes, and options for preparing for those changes.

What's New in Testing Pharmaceuticals for Metals: Metals and Limits in Limbo

In this column, Bob McDowall discusses the impact of USP general chapter 1058 on the spectroscopy laboratory.

USP <1058> Analytical Instrument Qualification and the Laboratory Impact

Tracing requirements from a user requirements specification throughout the life cycle is not only a very effective business tool to save time and effort in validation projects but also a regulatory expectation. This first installment of a two-part column series looks at the principles of a traceability matrix.

Validation of Spectrometry Software: The Proactive Use of a Traceability Matrix in Spectrometry Software Validation, Part I: Principles

This report demonstrates that it is possible to meet and exceed EPA "statement of work" requirements using ICP-MS.

Regulatory Standards/GLP/GMP Compliance