Articles
US Pharmacopeia Pharmaceutical Waters Part 3: General Information Chapters
August 21, 2009
•Feature Article: US Pharmacopeia Pharmaceutical Waters Part 3: General Information Chapters
By Roger Dabbah
The first article in this series discussed standard requirements for bulk waters in the United States Pharmacopeia (USP). The second dealt with packaged pharmaceutical waters and issues involved in harmonization of pharmaceutical waters among pharmacopeias. This final installment mainly deals with the USP general information chapters on pharmaceutical waters. It also reviews FDA's Guide to Inspections of High-Purity Water Systems (1), which is used by the agency's compliance inspectors.
USP general information chapters are developed by expert committees that convey to manufacturers and FDA inspectors credible information constituting a framework for production of pharmaceutical waters of appropriate quality. These chapters, all numbered greater than 1000, are not enforceable for compliance by the FDA, but some of their features may appear in FDA guidelines for use by its field inspectors.
In USP 28–NF 23 (2), including its supplements, two general information chapters on pharmaceutical waters were published: <1230> Water for Health Applications and <1231> Water for Pharmaceutical Purposes. Currently in preparation is general information chapter <1232> Instrumentation for Water Analysis.
Reprinted with permission from BioProcess International 4(5):18-23 (May 2006)
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