Regulatory Standards/GLP/GMP Compliance

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

May 16, 2014


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.

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

May 01, 2014


This article covers the changes so far to United States Pharmacopeia (USP) chapters and , 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.

USP <1058> Analytical Instrument Qualification and the Laboratory Impact

April 01, 2009


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

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

November 01, 2008


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.

Meeting Requirements of the EPA Contract Laboratory Program ILM05.3 Using Inductively Coupled Plasma-Mass Spectrometry: An Update

January 01, 2006


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