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US Pharmacopeial Convention seeks packaging community input

General Chapter 1083 on ‘Good Storage and Shipping Practices’ could replace General Chapter 1079.

USP’s new general chapters on good distribution practices focus on four key areas essential for a robust drug product supply chain.
USP’s new general chapters on good distribution practices focus on four key areas essential for a robust drug product supply chain.

In the following question-and-answer article, Healthcare Packaging (HCP) talks with Dr. Desmond G. Hunt, Ph.D., Senior Scientific Liaison, United States Pharmacopeial Convention (USP), about USP developments pertaining to temperature-sensitive packaging and how packaging professionals can get involved in the development of USP’s new general chapter <1083> on supply chain integrity.

HCP: Describe USP and its involvements.

Dr. Desmond G. Hunt: The United States Pharmacopeial Convention (USP) is a nonprofit scientific organization that develops standards for the identity, strength, quality, and purity of drugs and their ingredients, which are published in the United States Pharmacopeia and the National Formulary (USP–NF). USP–NF includes monographs, general chapters, and General Notices. A monograph is developed for a single article (e.g., drug substance, drug product, excipient), while a general chapter can apply across multiple articles. Above 1000 general chapters are intended to be informational, and contain no mandatory requirements unless specifically referenced in a monograph, General Notices, or a general chapter numbered below 1000. General chapters designated as below 1000 contain tests that are generally intended to be components of monographs for items recognized in USP or NF. Enforcement of applicable USP-NF standards is the responsibility of FDA and other government authorities in the U.S. and elsewhere; USP has no role in enforcement.

Healthcare Packaging: What developments should packaging professionals be aware of regarding US Pharmacopeia Guidance on temperature-controlled supply chain issues?

Hunt: In 2012, we introduced a new general chapter, <1083>, which deals with supply chain integrity. The goal for this chapter was to serve as a sister chapter to <1079> General Storage and

Distribution Practices for Drug Products. We had our workshop in May 2012, during which we hoped to gain input from stakeholders as to whether we were moving in the right direction by developing this new chapter.

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