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Product Development

Stability Studies: Planning Shelf Life You Can Defend

6 min read

Shelf life should not be treated as a number added to the label at the end of product development. It should be supported by a planned stability strategy.

1. What Is Stability Trying to Demonstrate?

A stability programme should help demonstrate that the product continues to meet appropriate quality requirements throughout the proposed shelf life under defined storage conditions.

Depending on the product, relevant attributes may include:

  • Assay
  • Physical characteristics
  • Microbiological quality
  • Moisture
  • Dissolution / disintegration where applicable
  • Appearance
  • Active markers
  • Packaging integrity
  • Other product-specific attributes

2. Start With the Product and Packaging

Stability does not belong only to the formula.

Consider:

  • Product
  • Formulation
  • Packaging
  • Storage
  • Transport
  • Target climate

The container-closure system can influence moisture, light, oxygen and other environmental exposures.

3. Consider the Target Market

A product intended for different climatic conditions may require an appropriate stability strategy for those conditions.

The intended storage statement should be consistent with the supporting evidence.

4. Define the Protocol

A stability protocol should clearly establish:

  • Batches
  • Storage conditions
  • Time points
  • Tests
  • Acceptance criteria
  • Packaging configuration
  • Sample quantities
  • Responsibilities
  • Deviation handling

5. Connect Stability to the Label

The final shelf-life statement should be supported by the available evidence. Avoid treating “24 months” as a marketing decision.

Instead ask:

  • What evidence supports this shelf life?
  • What storage condition applies?
  • Does the packaging configuration match the study?
  • Are the acceptance criteria appropriate?

6. Build Stability Into Product Development

A useful development sequence is:

  1. 01Formula
  2. 02Packaging
  3. 03Specification
  4. 04Stability protocol
  5. 05Stability data
  6. 06Shelf-life justification
  7. 07Label storage / expiry information

Conclusion

A defensible shelf life is the result of a planned evidence strategy.

It should connect the formula, packaging, storage conditions, testing and intended market.

Need support planning a product stability strategy?

Share the product, the pack and the markets you are planning for. We will help scope a protocol proportionate to both.

Discuss Your Requirement

Stability requirements vary by product category, jurisdiction, dosage form and intended storage conditions. The appropriate protocol should be scientifically and regulatorily justified.