Mitigating supply chain risk has always been top-of-mind for pharma logistics providers but rapid regulatory change is making risk management more critical than ever before. This was highlighted at the recent Asia-Pacific 3PL Summit & Chief Supply Chain Officer Forum in Singapore where Zuellig Pharma Corporate Head of Quality Assurance Brett Marshall discussed strategies to build resilience.

“A robust risk mitigation strategy looks at all aspects of the supply chain to ensure there are no ‘weak links’ that could cause a quality or regulatory incident. It needs to establish the business requirements for supply chain continuity; the points where the supply chain begins and ends; whether the sourcing strategy aligns with the business continuity requirements and training for employees and partners to ensure they can manage a crisis if it were to occur.”

Zuellig Pharma uses ICH, ISO and FMEA standards when proactively mapping supply chain risk.

“Utilizing existing tools allows us to ensure consistency across our own facilities and helps us align our practices with those used by our key partners and suppliers across the region.”

Evolving drug portfolios and fast-paced regulatory change is putting additional pressure on drug manufacturers and distributors to step up their risk mitigation standards and processes. Mr Marshall said new areas of focus are also beginning to emerge.

“Updates to the 2013 European Union Good Distribution Guidelines established a much more comprehensive framework for all parties to work towards. This framework more clearly defines the role of each player across the supply chain and increases the focus on controlled room temperature drugs as well as transit temperatures and processes.”

Data integrity is another area that is growing in importance and regulators are prosecuting lapses across borders said Mr Marshall. “50 Good Manufacturing Practice warning letters were given out in the US in 2015. 19 of these were a result of inspections that happened outside of the US and 15 of the 19 were related to data integrity.” Manufacturers are responding to this increased regulatory scrutiny. “Our clients need assurance that the data gathered by Zuellig Pharma is complete, intact and maintained within its original context. We have developed a number of tools, training modules and processes to ensure that the data we are capturing and holding for our clients is protected from modification, falsification or deletion. This has become a critical part of our supply chain resilience strategy, and the reliance strategies put in place by our clients.”