By Shawn Cai, Senior VP Development & Manufacturing, Rebecca Coutts, General Manager Tredegar, Rob Jones, Executive Business Development Director, and Kate Smith, Director of Quality, PCI Pharma Services
How robust is your strategy? Are you prepared for supply chain interruption? In today’s turbulent world, risk mitigation strategies are a must – and having a secondary supplier in place for the manufacturing and packaging of life-saving critical medicines should be an essential part of your strategy in terms of patient health.
Whether they know it or not, patients are heavily reliant on complex supply chains for sometimes life-saving medications – and that’s why good supply chain management has always been important for the industry, particularly in the case of critical medicines. However, the COVID-19 pandemic, natural disasters, the war in Ukraine, disruption in labor through staff shortages, and other events in recent years have emphasized how vulnerable the industry’s supply chains truly are and underlined the crucial importance of robust risk mitigation strategies. In addition, the threat of disruption in the supply of equipment, components, and materials – including raw materials – is also a significant risk.
PCI Pharma Services is a leading global CDMO providing integrated development, manufacturing and packaging solutions on behalf of clients. Conversations with our clients are now delving deeper into supply chains than ever before, with clients asking what else they can do to mitigate risk and ensure continuity of supply of life-changing therapies to their patients. The FDA has also accelerated such discussions by releasing draft guidance “Risk Management Plans to Mitigate the Potential for Drug Shortages, May 2022” for the industry on the need to have robust risk management plans to mitigate the potential for drug shortages.