Issue link: https://www.e-digitaleditions.com/i/1462155
Pharmaceutical Technology QUALITY AND REGULATORY SOURCEBOOK EBOOK MARCH 2022 47 to plan for longer lead times into their production schedules; ports are constantly seeing high con- gestion levels and vessel arrival delays; air cargo demand is being driven by sea freight capacity; and all of these issues have significantly increased the cost and adversely impact drug supply availability. COVID also limited the labor force availability worldwide. But for the pharmaceutical industry, it is a more dire situation as the pharmaceutical industry requires highly trained workforces that have significant knowledge, experience, and skills. To further examine the impacts, supply inter- ruptions have adversely impacted the on-time de- livery of much-needed materials, including APIs, raw materials, and packaging components to drug manufacturers. Speaking to the supply of API, there have been instances of increased leadtime on API supplies due to COVID cases at manufac- turing plants. Allowing for a few extra weeks in forward planning and supplier leadtime can mini- mize this impact. In turn, bulk product and fin- ished goods could face delays to customers, which can disrupt patient access for critical and life-sav- ing medicines. It is essential to procure materials and manufacture and ship products in advance to compensate for shipping delays, whether utilizing air or sea freight. This approach will continue to be required until the congested state of the global supply chain is reduced on a sustained basis. Lenox (LGM Pharma): Supply chain interruptions are a big contributor to drug shortages and in- creasing drug costs, both ongoing problems that regulators and the pharmaceutical industry work to address on a continuous basis. Drug shortages may arise from a variety of issues, including a lack of sufficient supply of APIs/raw materials/ excipients, and increased demand combined with insufficient materials are resulting in rapid price inf lation in the pharmaceutical market. Supply chain complications, unforeseen closures, regula- tory shutdowns and logistical delays also are fac- tors that affect pharmaceutical manufacturing and drug availability. Kirk (Catalent): The impact of the supply chain on manufacturing can be everything from minor to dramatic. At the highest level of severity, a supply shortfall can stop manufacturing and could result in delays to clinical trials and life-saving treatments not reaching patients. Even less severe events, such as a partial or late delivery of needed materials, can disrupt manufacturing and divert resources. It is for these reasons that companies should take great care and pay attention to monitoring the entire supply chain and always look for ways to improve business continuity measures. Pandemic impact PharmTech: Are there unique quality considerations that have arisen because of the COVID-19 pandemic that companies should be aware of when it comes to distribution and transportation of products? Ojinaka (Astrea Bioseparations): Logistic and shipping disruption, specifically for temperature-sensitive products, could prove tricky and needs to be con- sidered carefully in the current state of [the] sup- ply chain. Unreliable forecasting due to changing COVID-19 restrictions has been a factor when con- sidering distribution inventories and transportation. Kirk (Catalent): The main point to note is that de- spite all the challenges presented during the pan- demic, the standards expected by regulators and customers did not change. Regarding distribution and transportation, it is important to ensure chain- of-custody throughout the supply chain where re-