COVID-19 Exposed Supply Chain Challenges, New Procedures Needed, Expert Says

COVID-19 exposed supply chain problems that should have pharmaceutical manufacturers rethinking their standard procedures — from sourcing manufacturing materials to getting completed product safely into customer hands, — says one regulatory compliance expert.

“That was an unprecedented event that exposed many gaps in supply chain issues,” said Sue Soderholm, a managing consultant at Compliance Architects. “Nothing like it had ever happened before in our lifetime.”

Although supply chain issues have improved in the past year as the pandemic has waned, challenges remain and may even increase over time, Soderholm told attendees at the WCG FDAnews Quality Management vSummit on Wednesday.

The conflict in Ukraine, extreme weather events fueled by global warming and ongoing regional COVID-19 lockdowns in China continue to throw wrenches into a procurement and delivery system that needs to work smoothly to provide optimal outcomes for companies and patients.

The pandemic didn’t just interfere with shipping. Vaccine research, development and distribution had direct effects on basic raw materials, like glass and the plastic used in medical devices. “There was a shortage of resins” needed to make medical-grade bags, Soderholm said.

These challenges are accentuated for companies whose supply chain systems data are still largely paper-based.

“A lot of smaller companies start very paper-based on Excel spreadsheets,” and while there’s no problem there in terms of compliance, she said, it’s very difficult to conduct paper-based data mining resulting in the meaningful information that can get a company through challenges like these.

“If you have the ability to automate using a validated qualified system, you should. You want to use a warehouse management system and then perhaps you also need some sort of supply chain analytics or systems, applications and products system,” she said.

“Bad data remains of little use even when migrated into systems, spreadsheets, warehouse management operations and similar integrations.”

Soderholm recommended adopting the FDA’s new risk management plan for mitigating the potential for drug shortages (DID, May 23).

“It does provide a phenomenal risk management plan. There’s an expectation that because it has issued this guidance, FDA is going to ask companies to see their risk management plan” for preapproval or annual inspections.” — Michele G. Sullivan