Launching in 2025? 7 Key Considerations for Supply Chain Readiness 

Title: Launching in 2025? 7 Key Considerations for Supply Chain Readiness 

Launching a pharmaceutical product requires meticulous supply chain readiness. Here are 7 key considerations:  

1. Optimal Launch Inventory for Finished Goods (FG):

The first consideration is aligning launch inventory levels with market expectations. Market demand forecasts, anticipated sales volumes, and shelf-life requirements from distributors must be analyzed to minimize the risk of stockouts or excess inventory. By employing scenario planning and optimization techniques, organizations can fine-tune their launch inventory strategy and maintain a balance between supply and demand. 

2. Inventory Planning for Key Raw Materials (RM), Drug Substance (DS)/Active Pharmaceutical Ingredients (API):

Efficient inventory planning for upstream materials is crucial for uninterrupted production and meeting market demand. Analyzing lead times, cost implications, and potential risks associated with each material is essential to mitigate supply chain disruptions. Collaborating with contract manufacturers to secure manufacturing slots and establishing alternative sourcing options can further enhance supply chain resilience. 

3. System of Record for Commercial Inventory:

Good Manufacturing Practice (GMP) calls for a reliable system of records for commercial inventory. An integrated inventory management system provides real-time visibility into stock levels, product movement, and expiry tracking. This enables accurate inventory tracking, order processing, and fulfillment, allowing seamless coordination between various stakeholders involved in the supply chain. 

4. Supply Planning Process & System:

Pharmaceutical supply chain planning demands meticulous attention due to stringent regulations, limited shelf life, extended lead times, and rigorous quality controls. Implementing a robust supply planning process and system, such as ABC-Plan’s Master Planner, allows organizations to navigate potential bottlenecks and disruptions proactively. By optimizing inventory levels, the risks of stockouts and inventory write-offs can be mitigated. 

5. Establish and Implement Sales and Operations Planning (S&OP) Process:

The S&OP process plays a pivotal role in aligning demand and supply activities, enabling effective decision-making across different functions. A cross-functional S&OP team meets regularly to develop comprehensive supply plans, align them with demand plans, production capabilities, regulatory requirements, and address potential bottlenecks or contingencies  

6. Set up Month-End/Quarter-End Reporting:

Accurate inventory reporting is not only Good Manufacturing Practice (GMP) requirement but also a requirement under the Sarbanes-Oxley Act (SOX). Implementing a robust reporting framework that captures critical inventory and financial data empowers organizations to submit accurate and transparent financial reports to auditors and shareholders.     

7. Inventory Management Standard Operating Procedures (SOPs):

Inventory management SOPs ensure consistency, compliance, and efficiency in inventory-related processes. SOPs should cover inventory tracking, reconciliation, batch status, expiration management, and returns handling. 

In conclusion, successful pharmaceutical product launches depend on a well-prepared and efficient supply chain. Considering these 7 key elements during the preparation process will enable organizations to meet market demand, maintain product availability, minimize risks, and establish a solid foundation for long-term success in the dynamic pharmaceutical industry.