Finished Product Expiry Planning
Ryan Mills · 2024
This chapter begins with a discussion of the first in first out (FIFO) and last in first out (LIFO) inventory management methodologies and how these concepts are applicable to managing expiry within the clinical supply chain. Then, it covers the importance of breaking aggregate on-hand inventory into individual batches so that expiry can be appropriately analyzed within the finished product production plan. The chapter provides guidance on how to choose a strategy for extending or replacing expiring lots and how to manage the dreaded expiry limitation. A challenge with respect to expiry management is confronting expiry period limitations on the drug product (DP). There are four situations where a limitation can occur, two related to the underlying stability of the DP and two related to interactions with the competent health authority. Analyzing the distribution planning strategy to determine if more frequent depot resupplies are required to replace expiring batches.