Issue link: https://www.e-digitaleditions.com/i/1462155
48 Pharmaceutical Technology QUALITY AND REGULATORY SOURCEBOOK EBOOK MARCH 2022 P h a r mTe c h . c o m quired; for example, for temperature-controlled shipments, there should be robust systems in place with approved suppliers to alert and report any ex- cursions. COVID-19's unique impact is the preva- lence and unpredictability of potential disruption. Colicchio (Dr. Reddy's Laboratories): COVID has drasti- cally reduced the cargo capacity, including tempera- ture-controlled services and pharma-certified carri- ers. For example, pharma companies must be vigilant when they subcontract trucking services. Sometimes the most cost-efficient option is not the ideal option for transporting pharma product. Pharma compa- nies are experiencing [significant] mode-of-transport changes to better accommodate timelines in delivery to customers. In pharma, we cannot simply change the mode of transport without properly evaluating the risk and gaining alignment from our quality and regulatory functional teams. PharmTech: For materials sourcing, how has the pandemic impacted the supply chain? What steps should companies take to ensure that the materials they are sourcing are of high quality and available when needed? Colicchio (Dr. Reddy's Laboratories): One key area of the supply chain to minimize drug shortages dur- ing the pandemic is to procure a higher volume of materials, including packaging components, to ensure that you always have sufficient safety stock to produce the required finished dosage drug prod- uct inventory. The recommendation—especially after applying the lessons learned from operating during the pandemic—is to procure three to four months of supply for APIs, critical excipients, and key packaging materials that carry long lead times. It is also important for the API manufacturers to have sufficient supplies of key starting materials (KSMs) to produce satisfactory API volumes. Material sourcing is also enabled by frequent supplier communication. Forecasts at least once per quarter for a rolling 12-month view provide the supplier with the visibility and the agreed conditions to have their manufacturing material released and ready for production when a pur- chase order is received. Also, robust facilitation of the impact to DMF [drug master file] changes or specification changes minimizes quality assurance release concerns relative to the availability of tested and released material for production. Ojinaka (Astrea Bioseparations): Increased delays to raw materials delivery from suppliers meant the Just-in-Time manufacture strategy was sig- nificantly impacted through the pandemic. Going for ward, improved forecasting aided by data analytics, an open communication link between supplier–organizations–customer, robust S&OP [sales and operations planning] set-up, and a buf- fer stock strategy will be key to maintaining reli- able supply chain. Kirk (Catalent): The pressure on the supply chain and reduced excess capacity has led to day-to-day challenges. To address these, additional scrutiny to the close monitoring and reporting of suppliers' delivery schedules should be applied, close rela- tionships and communications with key suppliers must be maintained, and closer internal collabora- tion with operations teams to adapt to any varia- tion in schedules should be adopted. Giving on- time, accurate forecasts helps both suppliers and manufacturers; we're all in this together. Lenox (LGM): The pandemic highlighted the im- portance of adopting a multi-source strategy and maintaining a geographically diverse supply chain, for clients and their suppliers. By qualifying mul- tiple facilities, as well as choosing facilities in dif- Regulations: Supply Chain