Background

During a recent FDA clinical inspection of a major pharmaceutical company, the auditor placed a strong focus on temperature excursion tracking of study drugs, from manufacture of product through to storage at the clinical sites. The inspector recommended improving the timeliness of excursion notifications to the sponsor and the comprehensive tracking of cumulative temperature excursions throughout their supply chain.

Challenge

The pharma company did not have a robust end-to-end process established for managing and reporting cumulative temperature data for excursions. The current practice was for their external supply chain partners to manage this work package. This process introduced the possibility that the sponsor would not be informed about excursions in a timely manner and drugs that had exceeded their cumulative time out of conditions could be administered to a patient. The company was about to embark on several large Phase III studies and felt they needed to address the auditor’s recommendation prior to starting these projects to avoid a 483 at future inspections.