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The Impact of USP <1079> on Cold Chain Management


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The Impact of USP <1079> on Cold Chain Management

Webinar Summary
The regulatory environment for the storage handling and distribution of pharmaceutical products has changed dramatically during the past year with the publication of U.S. Pharmacopeia (USP) <1079> “Good Storage and Shipping Practices” in November of 2005.

This document provides guidance for ensuring a pharmaceutical product’s “identity, strength, quality and purity” across the entire distribution channel. As described in USP General Chapter <1079>, once an article leaves the manufacturer’s chain of control it enters a complex distribution system that involves many handoffs, outsourced service providers and supply chain intermediaries—all before reaching the patient. It is during this complex stage of distribution when most temperature excursions occur.

In order for pharmaceutical companies to support Good Cold Chain Management Practices (GCCMP), they must re-evaluate their cold chain distribution systems based on the recent USP updates.

In this Webinar, titled “The Impact of USP <1079> on Cold Chain Management,” Dr. Bishara:

	Gave an overview of global cold chain regulations
	Focused on the importance of USP guidance in cold chain management
	Highlighted the updates in USP General Chapter <1079> “Good Storage and Shipping Practices”
	Offered strategic yet practical methods for complying with the newly published USP guidance changes

Following Dr. Bishara’s presentation, Sensitech’s VP & GM of Life Sciences, Bill Schwarz, gave a brief description of Sensitech’s shipping and thermal mapping studies. These solutions are geared toward meeting regulatory demands.

A question-and-answer session followed both presentations.

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Rafik H. Bishara, Ph.D.,
was employed by Eli Lilly and Company for 35 years. He is the current Chair of Parenteral Drug Association’s (PDA) Pharmaceutical Cold Chain Discussion Group. He received his doctoral degree from Purdue University. Dr. Bishara has been a leader and member of several well-known guidance and regulatory compliance organizations, including USP-Packaging, Storage and Distribution (PSD) Project Team; PhRMA Stability Expert Team; PhRMA Compendial Liaison Team; PDA Stability Interest Group; Midwest Compendial Discussion Group; among others.