Resources by service
Major Pharma Company Implements Food and Drug Administration (FDA) Recommendations
During a recent Food and Drug Administration (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. This was vital as 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 and to avoid a 483 at future inspections.
The main challenge was that 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 inspector recommended improving the timelines of excursion notifications to the sponsor and the comprehensive tracking of cumulative temperature excursions throughout their supply chain.
Almac’s temperature management solutions service can collect and maintain temperature excursion data at the lot or Medical ID level from manufacture until the drug is administered to the patient. We have a dedicated team of temperature experts to support your decision making when faced with challenges throughout your clinical trials. Click here to discover more about Almac Clinical Services
*By submitting your information you acknowledge that you have read the privacy statement and you consent to our processing the data in accordance with that privacy statement. We may, from time to time, send you material relevant to your interests. If you change your mind at any time about wishing to receive material from us, you can send an email to firstname.lastname@example.org. Every email we send you will also include an unsubscribe link so you can unsubscribe from our marketing list.