Speciality Chemicals Magazine JUL / AUG 2021 | Page 53

SUPPLY CHAIN MANAGEMENT

Nearly 50 % of the pharmaceutical supply chain leaders surveyed by TraceLink feared they lacked the required agility to survive major business disruptions . ¹ A partner who cannot react swiftly to changes in demand or access resources may not have what it takes to keep a drug strategy agile and ready for whatever comes . One strategy to consider is not just having multiple partners on paper but keeping them active . There is a greater chance of having needs fulfilled if the ask is to increase a forecast to a supplier , rather than coming in cold from an un-forecasted position .

No-confidence partnerships

When confidence in a supplier is in short supply , programme efficiency and critical decision-making can suffer . Figures suggest that 65 % of pharmaceutical supply chain professionals can no longer plan their supply accurately . ¹ If it is hard to get commitments or suppliers do not return calls , planning becomes extremely difficult . If drug programme managers are unable to predict supply accurately , due to late , bad or non-existent data from their suppliers , they will have low confidence in their plans and even lower confidence in the continuity of their drug strategies and product plans . While it is impossible to know everything that might be coming around the bend , it is important that

API suppliers have the capacity , experience and a rapid response to tackle and mitigate against issues that threaten reliable delivery . How can pharmaceutical companies ensure their API supplier has the capacity and flexibility to be secure and reliable ? Start with an open , honest dialogue about their business continuity and crisis response strategies . Also , seek insight into a potential partner ’ s manufacturing capabilities especially when it comes to production processes and chemistries , quality , tech transfer and scale-up .

Process and quality

Some API suppliers have taken less expensive routes of synthesis that have ended up causing contamination in many products , leading to delays and disruptions in the supply of APIs . The resulting financial losses and potential legal costs can be extremely high . According to the US FDA , 62 % of the 163 drugs that went into shortage between the calendar years 2013 and 2017 did so after supply disruptions associated with product quality problems . ^{4 , 5} Drug companies should ensure that all of their API suppliers have the quality management processes in place to provide consistent , highquality supply . One solution supported by the FDA ’ s Task Force on Drug Shortages proposes a rating system to inform purchasers , group purchasing organisations for healthcare systems and even consumers , about the quality management maturity of the facilities making the drugs . ⁵ Janet Woodcock , director of the FDA ’ s Centre for Drug Evaluation & Research , has argued that the effort would introduce transparency into the market and support those suppliers committed to high quality standards . ⁴

Outlook

There are many hidden and notso-hidden dangers threatening API supply chain security . Being prepared to respond to disruptions and hardto-see vulnerabilities as rapidly as possible is key . There are supply chain partners that have the capacity , capability and global reach to support drug companies in addressing gaps in their API supply chain that can lead to costly disruption . Pfizer CentreOne , for example , constantly monitors its own supply chain partners to tackle vulnerabilities and ensure it can act as a reliable and sustainable partner for pharmaceutical companies even in the most challenging market conditions . By seeking out and engaging with flexible and vigilant commercial API suppliers , pharma companies can be confident they have the tools at their disposal to build and maintain a resilient supply chain . •

Ken Ball

API & INTERMEDIATES COMMERCIAL LEAD

JUL / AUG 2021 SPECCHEMONLINE . COM

53