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Healthcare Packaging goes to Washington: Part II of a four-part series

An update on the U.S. Pharmacopeial Convention in Rockville, MD.

USP’s Desmond Hunt, Senior Scientific Liaison, and Theresa Laranang-Mutlu, Public Relations Manager, point out that as an independent, not-for-profit organization, USP’s general chapter standards numbered above 1,000 aim to be informational, while standards below 1,000 are intended for mandatory use. Either may apply when called out in particular monographs, and may also be FDA-enforceable.

Hunt’s area of focus is in packaging, storage, and distribution, and these issues are global in nature. He points out the importance of compendial standards, in light of recent quality issues related to product recalls (some resulting in drug shortages), and an increasing number of FDA inspectional observations (Form 483) and Warning Letters.

He mentions that USP is in the midst of major revisions to General Chapter 661, where sections of the chapter predate the 1970s.

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Break out of the ordinary: see what’s new in life sciences packaging
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