Shelf Life in the Life Sciences Supply Chain: Tips & Tricks
Gain a competitive advantage by optimizing your product shelf life!
Effective shelf life management in Life Sciences supply chains is crucial for patient safety, regulatory compliance, product quality, business efficiency and brand reputation.
How to manage shelf life?
For biopharmaceutical products an effective shelf life management involves a combination of meticulous quality control, pro-active inventory management and strategic decision-making. Inventory tracking, FIFO or FEFO strategies, alert systems, repackaging and relabelling are some examples of measures that can be taken to ensure that biopharmaceutical products remain safe and effective throughout their designated shelf life and to minimize wastes.
Taking a step back and moving up the chain, a smart production planning which takes into account the different parameters and constraints can be a very effective way to avoid, from the very beginning, the production of material that will end up discarded. Scenarios planning also offers a great opportunity to anticipate and measure the risks.
Life Science products: specific challenges
For biopharmaceutical products, the shelf life typically starts at the time of Drug Product (DP) production. This means that at the time of the final finished product (FP) release for distribution or sale, part of the product’s shelf life may already be consumed.
Moreover, in the pharmaceutical industry, the stability of a Drug Product is often influenced by the time between the DP’s formulation and packaging. The maximum allowable time between formulation and packaging, commonly referred as “packaging window” is a critical consideration ensuring the product’s stability and shelf life.
As importantly, country regulations and distributors may require pharmaceutical products to have a minimum remaining shelf life upon order to ensure patient safety, maintain product efficacy, uphold quality standards and facilitate inventory management.
Optimizing production plans at all levels (Finished Product, Semi Finished Product, Drug Product and Active Pharmaceutical Ingredient) involves not only fulfilling demand while considering production constraints but also deeply understanding shelf life specific requirements and integrating them in the planning cycles.
Our solution to manage shelf life...
The Demand and Supply Engine developed by SCO allows to modelize the Supply Chain with all the related parameters:
- demand assumptions
- supply assumptions
- supply flows
For the specific point of view of the shelf life management the Engine will, among others, integrate: global shelf life for API and for DP/SFP/FP; minimum remaining shelf life required by country regulations or distributors; DP stability constraints; lead-times for all the production and distribution steps as well as safety stocks.
Based on the parameters included in the model, the Demand and Supply engine will calculate production plans at all levels aimed to avoid both product shortages and obsolescence leading to scrapping.
The strength of the tool lies not only in its ability to provide optimized production plans based on given parameters, but also in the fact that the model itself allows a better understanding of the interaction and impacts of the different assumptions.
The ease of simulating different scenarios offered by the Demand and Supply Engine is a key advantage to rethink the model as a whole and redesign it to mitigate risks related to shelf life constraints.
In summary, effective shelf life management is crucial for patient safety, regulatory compliance, product quality, economic efficiency, and brand reputation in the pharmaceutical industry. By implementing measures and utilizing tools like the Demand and Supply Engine, pharmaceutical companies can ensure that their products remain safe and effective throughout their shelf life, while also minimizing waste and maximizing efficiency.
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