USP on Investigational Drug Storage and Transport

[membership level=”0,4″][The content continues for paid members only.] Login or Subscribe [/membership][membership level=”1,5,6,7,8,9,10,11,12″][membership] In its June/July Pharmacopeial Forum, USP presented a new draft subchapter (<1079.1>) on storage and transport of investigational drug products (IDPs), as an addition to its “Good Storage and Distribution Practices for Drug Products” (<1079>). The IDP subchapter stresses the need for environmental monitoring and supply-chain integrity throughout the distribution process, and provides a detailed method for calculating a “rating of shipment risk” based on early risk-assessments in the distribution process. The chapter explains key differences between IDP and commercial distribution. IPD quantities are • often small, as little as unit dosage packages • transported to many different sites • often a new chemical entity lacking robust stability data, and • often in the early stages of clinical trials. The document stresses that, “a temperature excursion of just a single container may jeopardize the entire clinical trial outcome.” Register to the USP Pharmacopeial Forum website to read the complete draft. The chapter is open for comment until September 30, 2016.
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