Product Stability
Product stability describes how a product retains its required properties over time under defined conditions. For medicines, these may include active substance content, purity and physical characteristics, depending on the product. Stability data form a basis for storage conditions, shelf life and the assessment of transport excursions.
Which information is relevant for shipping?
- The specific product, its packaging and its state: an unopened medicine may have different requirements from an already prepared solution.
- Permitted conditions and demonstrated exposure limits: temperature and duration must not be considered independently.
- The documented temperature history, including relevant previous exposure when assessing an excursion.
What role does thermal packaging play?
Suitable packaging is intended to maintain the specified conditions. Its demonstrated duration describes packaging performance and is not a product property. Following a temperature excursion, the responsible quality assurance team assesses usability using suitable product data and defined procedures. An unchanged appearance alone does not demonstrate unchanged quality.
Related terms: Stability Budget · Qualification
Technical references:
EMA: ICH Q1A(R2), Stability testing
EU GDP Guidelines: particularly Chapter 9