Raw materials play an integral role in pharmaceutical manufacturing to support the target product profile. The availability of critical raw materials has been a recurrent theme in recent years and the recent COVID-19 pandemic has introduced additional layers of complexity in this already challenging environment. Among those COVID-19 related challenges are; a lack of real-time supply chain transparency; the need for businesses to flex with a surge in material demands; the need to manage an increase in supplier change notifications etc. The development of risk mitigation measures to circumvent raw material stock outages serves as a primary component of a robust business continuity plan.

We will outline pragmatic strategies that may serve to reduce the risk of material supply chain shortages. Such strategies are key to effective and efficient product commercialization. This case study will illustrate the value of a practical risk-based approach towards managing raw material substitutions and outline key considerations in evaluating and executing raw material substitutions and second sourcing strategies. A sample decision tree approach will be presented designed to enable right-sizing technical evaluation of raw material substitutions across both compendial and non-compendial raw materials. The appropriate application of prior knowledge in this regard will also be discussed.

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