In pharmaceutical manufacturing, shelf-life is not just a quality attribute. It is a critical planning
constraint. Every batch of drug product has a finite lifespan, and once a product’s remaining
shelf life falls below regulatory thresholds, usually six months, it can no longer be distributed to
pharmacies, wholesalers, or patients.
At FDA approval, a new product’s shelf-life may be as short as 18 to 24 months. But by the time
it is shipped, packaged, validated, and ready for market, valuable time has already been lost.
Combined with large batch sizes and slower than expected demand, this creates a perfect
storm of inventory obsolescence risk.
Why Shelf-Life Risk is a Planning Problem
If the full lot size exceeds market demand, leftover inventory may expire before it can be used.
This results in waste, lost revenue, and potential drug shortages. Planners must account for this
reality while balancing availability, compliance, and patient safety.
To complicate matters further, pharmaceutical batches must undergo ongoing stability testing.
As new data becomes available, often from long term or accelerated studies, shelf life may be
extended. But unless your planning system can anticipate those changes and adjust accordingly,
you are operating without full visibility.
Shelf-life stability is influenced by:
- Temperature – Heat accelerates chemical degradation
-  Humidity – Moisture can chemically react with drug compounds
- Light – UV exposure can reduce potency over time
Planning Systems Must Handle Shelf-Life Intelligently
Effective pharmaceutical planning requires real time visibility into remaining shelf-life, batch
level tracking, and the ability to exclude or include batches dynamically based on current and
projected expiration windows.
Yet many ERPs and legacy planning systems either ignore shelf-life altogether or require
cumbersome manual workarounds. This leads to:
- Obsolescence risk
- Unexpected shortages
- Poor production planning
Supply planners need more than stock counts. They need insight into expiration, the ability to
exclude aging inventory from future demand coverage, and the flexibility to include it again if
stability data justifies a shelf-life extension.
How SCmple Solves It
SCmple was purpose built to handle this complexity. Our solution gives pharma planners the
tools to:
- Track batch level shelf life and expiry dates in real time
- Simulate the impact of shelf-life extensions
- Exclude at risk inventory from supply coverage
- Minimize waste while maintaining compliance
With SCmple, you can plan smarter, reduce obsolescence, and keep lifesaving medicines
flowing to patients on time and in specification.