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34 BioPharm International Quality and Regulatory Sourcebook eBook March 2022 www.biopharminternational.com suppliers are now forced to plan for longer lead times into their produc- tion schedules; ports are constantly seeing high congestion levels and ves- sel arrival delays; air cargo demand is being driven by sea freight capacity; and all of these issues have signif i- cantly increased the cost and adversely impact drug supply availability. COVID also limited the labor force availabilit y worldwide. But for the pharmaceutical industry, it is a more dire situation as the pharmaceutical industry requires highly trained work- forces that have significant knowledge, experience, and skills. To further examine the impacts, supply interruptions have adversely impac ted t he on-t ime del iver y of much-needed mater ia ls, inc lud ing APIs, raw materials, and packaging components to drug manufacturers. Speaking to the supply of API, there have been instances of increased lead- time on API supplies due to COVID c a s e s a t m a n u f a c t u r i n g p l a n t s . A l low ing for a few extra weeks in forward planning and supplier lead- time can minimize this impact. In t u r n , bu l k pro duc t a nd f i n i she d goods could face delays to customers, which can disrupt patient access for critical and life-saving medicines. It is essential to procure materials and manufact ure 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 globa l supply chain is reduced on a sustained basis. Lenox (LGM Pharma): Supply chain interruptions are a big contrib- utor to drug shortages and increas- ing drug costs, both ongoing problems that regulators and the pharmaceutical industry work to address on a contin- uous basis. Drug shortages may arise from a variety of issues, including a lack of sufficient supply of APIs/raw materia ls/excipients, and increased demand combined with insuff icient materials are resulting in rapid price inf lation in the pharmaceutical mar- ket. Supply c ha i n compl ic at ions, unforeseen closures, regulatory shut- downs and logistical delays also are factors that a ffect pha rmaceutica l 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 reach- ing patients. Even less severe events, such as a partial or late deliver y of needed materials, can disrupt manu- facturing 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 busi- ness continuity measures. PANDEMIC IMPACT BioPharm: Are there unique quality considerations that have arisen because of the COVID-19 pandemic that com- panies should be aware of when it comes to distribution and transporta- tion of products? Ojinaka (Astrea Bioseparations): L og istic and shipping d isr uption, specif ica l ly for temperat ure-sensi- tive products, could prove tricky and needs to be considered carefully in the current state of [the] supply chain. Unreliable forecasting due to changing COV ID-19 restrictions has been a factor when considering distribution inventories and transportation. Kirk (Catalent): The main point to note is that despite all the challenges presented during the pandemic, the standards expected by regulators and customers did not change. Regarding distribution and transportation, it is impor tant to ensure chain-of-cus- tody throughout the supply chain where required; for example, for tem- perature-controlled shipments, there should be robust systems in place with approved suppliers to alert and report any excursions. COVID-19's unique impact is the prevalence and unpredict- ability of potential disruption. C o l i c c h i o ( D r . R e d d y ' s Laboratories): COVID has drastically reduced the cargo capacity, including temperature-controlled services and pharma-certified carriers. For example, pha r ma compa n ies must be v ig- ilant when they subcontract trucking services. Sometimes the most cost-ef- ficient option is not the ideal option for transpor ting pha rma product. Pharma companies are experienc- ing [signif icant] mode-of-transport changes to better accommodate time- lines in deliver y to customers. In pharma, we cannot simply change the mode of transport without properly evaluating the risk and gaining align- ment from our quality and regulatory functional teams. BioPharm: For materials sourcing, how has the pandemic impacted the supply chain? What steps should com- panies take to ensure that the materials they are sourcing are of high quality and available when needed? C o l i c c h i o ( D r . R e d d y ' s Laboratories): One key area of the supply chain to minimize drug short- ages during the pandemic is to pro- cure a higher volume of materials, inc lud ing pack ag ing components, to ensure that you always have suf- f icient safet y stock to produce the required f inished dosage drug prod- uc t inventor y. T he recommenda- tion—especially after applying the lessons learned from operating during the pandemic—is to procure three to four months of supply for APIs, crit- ica l excipients, and key packaging materials that carry long lead times. It is also important for the API manufac- turers 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 Quality and Regulatory Sourcebook Regulations: Supply Chain