Stability programme designed to ICH Q1A(R2)
Ergopharm has designed its stability programme to ICH Q1A(R2), fixing the storage conditions, testing frequency and study design that would support the shelf life of every product it later releases.
Shelf life is not an opinion; it is the conclusion of a study designed before the first batch is made. Q1A(R2) sets out what that study must contain: long-term conditions appropriate to the intended climatic zone, accelerated conditions to reveal degradation quickly, and intermediate conditions to be used when the accelerated data show significant change.
“An expiry date is the output of a study, not a decision taken at the end of the line.”
The programme runs long-term at 25 °C/60% RH and accelerated at 40 °C/75% RH, with 30 °C/65% RH available as the intermediate condition, and the hotter zone conditions applied where the destination market requires them. Testing frequency follows the guideline — quarterly in the first year, six-monthly in the second, annually thereafter — and methods used are stability-indicating, meaning they can separate and quantify degradation products rather than merely confirm the assay.
Every commercial product carries at least one batch a year on ongoing stability, so that shelf life is not established once and assumed thereafter.
Key facts
- Guideline
- ICH Q1A(R2)
- Long-term
- 25 °C / 60% RH
- Accelerated
- 40 °C / 75% RH; intermediate 30 °C / 65% RH
- Ongoing
- At least one commercial batch per product per year
This notice describes Ergopharm’s own packaging and processes and how they follow published standards; it does not assert a specific national marketing approval.