Does your company handle investigational drug products (IDP) the same as your commercial products? If so, you may want to consider the proposed new USP chapter on storage and transport of IDP as an addition to the Good Storage and Distribution Practices for Drug Products chapters . This new subchapter should focus on investigational drug products (IDPs; investigational medicinal products in Europe, IMPs). Transport of small quantities of product to multiple sites, minimal stability data, temperature excursions of single containers along with different distribution requirements in various countries make this a challenge for most companies. To address these challenges, the new chapter proposes the following requirements:
- Storage in a safe and secured area at labelled storage conditions
- Segregation for IDPs not 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 labeling
This new chapter also gives a detailed example for calculating a rating of shipment risk to help identify probability and impact of errors in the supply chain.
Read more on the USP Pharmacopeial Forum.