Regulatory Focus

REGULATORY FOCUS: Measuring Porous Microbial Barriers: Part I

The work behind ASTM International Standard Test Method F2638.

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ASTM Addresses Machine Life

New standard, which includes packaging equipment, will help users determine the fitness of all systems used for drugs, biologicals, and even medical devices.

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Tighten Foreign Inspections

A petition to FDA calls for clearer inspection policies. Until then, consumers may have to scrutinize such imported products as toothpaste.

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New 2-D Bar Code

DotCode-128 accepts a wide variety of printer options and printing media.

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Standardized Security for Security Products

A group tightens control over security graphics, with an eye on new risks.

By Daphne Allen
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Centralizing Security

The North American Security Products Organization (NASPO) has opened its new offices at 1425 K St. N.W., Washington, DC, 20005.

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USP Proposals Related to Packaging: A Call for Industry Response

Pending changes to the packaging requirements in the USP may affect pharmaceutical manufacturers. Results from a pulse-style survey of eleven U.S. pharmaceutical packaging professionals show that industry’s participation in the USP revision process is limited and in need of improvement.

By Dwain L. Sparks, Associate Consultant, Global Packaging Technology and Development Eli Lilly and Co.

A large proportion of the packaging materials used for pharmaceutical products in the United States follow the requirements described in the United States Pharmacopeia (USP).

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USP General Information and USP Structure


A collection of public, published standards that has been given official status as quality standards for drugs, biologics, medical devices, active ingredients, dietary supplements, and excipients. The standards in the United States Pharmacopeia and the National Formulary (USP—NF) are enforceable under U.S. laws. The term “compendium” is generally used interchangeably with “pharmacopeia.”


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USP Organization and Governance