Storage and Transport: New USP Chapter for Investigational Drug Products

Recommendation

14-16 May 2025
Vienna / Schwechat, Austria

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In the Pharmacopeial Forum 42(4) [Jun-Jul 2016], the General Chapters - Packaging and Distribution Expert Committee of the U.S. Pharmacopeial Concention (USP) proposed a new chapter as an addition to the Good Storage and Distribution Practices for Drug Products chapters [1079]. This new subchapter should focus on investigational drug products (IDPs; investigational medicinal products in Europe, IMPs).

In the introduction, USP acknowledges that IDPs differ from commercial products:

Small quantities for many different sites
Less stability data available especially for early phases of clinical trials
Temperature excursions of a single container "may jeopardize the entire clinical trial outcome"

Another challenge are different distribution requirements for IDPs in various countries. Sponsors should be aware of this.

The key expectations specified in the proposed new chapter are:

Storage in a safe and secured area at labelled storage conditions
Segregation for IDPs not or not yet dispensed yet and for IDPs awaiting return to sponsor or contractor
Site qualification audits need to be performed
Anticipation and tracking of expiry or re-test extensions (according to different local regulatory requirements)
Packaging qualifications should be the same as for commercially available drug products
Consideration of important distribution risk factors (e.g. distance, time, temperature, handoffs, packaging)
Confirmation that proper steps are taken to ensure IDP supply chain integrity (including checklists for patients)
Unblinded IDPs should be quarantined
Comparators should be shipped and stored according their (new) IDP labelling

The draft chapter also gives a detailed example for calculating a rating of shipment risk that can help to identify probability and impact of missteps in the supply chain.

The deadline for comments is September 30, 2016

After registration on the USP Pharmacopeial Forum website the complete drafts can be accessed.