If you haven’t begun this process here are some things to think about.
Facilities/supply
Think about where your manufacturing facilities are located, the risks to ongoing manufacturing activities, and impact to the supply chain. Are you prepared for delays? For shortages?
Workforce
What measures has your company implemented to prevent spread of the virus within the workplace? What is the risk to your supply chain if you were to suffer a sudden loss of workers? Do you have transition plans in place, and good knowledge management practices? Will there be further support to allow workers to work from home either as a preventative measure or if they should be subject to an extended quarantine period? Do you have a pandemic business continuity plan? Have you identified which critical personnel will be needed on campus and who can function off campus? Does your company have the necessary protective materials (e.g., N95 respirators) in place?
Distribution routes
How are your distribution plans prepared for disruptions and delays as border crossings become bottlenecks or distribution channels begin to shut down? Do you support direct-to-patient distribution if subjects cannot get to sites? If so, what do you do to ensure quality and integrity of the clinical supply during transit, as well as patient privacy, and patient compliance? How will you support ongoing patient care? Has your company considered Direct-to-Patient so you can be able to supply critical patients with timely investigation products? This is the time to ensure your company and your domestic and international carriers are working closely together to ensure critical IP can be delivered to the most critical patients.
Clinical Trial planning
Will trials still be started as planned? Go to the same countries? Will the trials continue to enroll as planned given high risk to subject participation and willingness to go to clinics? Will the visit schedule be altered to lessen the need to visit a clinic? Will the comparator agent stay the same or need to change due to supply chain disruptions?
What best practices is your company putting into place as you prepare for a potential pandemic?
iSpeak Blog posts provide an opportunity for the dissemination of ideas and opinions on topics impacting the pharmaceutical industry. Ideas and opinions expressed in iSpeak Blog posts are those of the author(s) and publication thereof does not imply endorsement by ISPE.
Part 2, Advance Your Pharma Supply Chain Planning during a Pandemic
