Overview
Conditions we run
Our stability chambers are sized and qualified for the temperature, humidity, and photostability conditions specified in the ICH Q1A(R2) and Q1B guidelines, the same conditions used by major pharmaceutical manufacturers to support a registered shelf life.
- Long-term: 25°C ± 2°C / 60% RH ± 5%
- Intermediate: 30°C ± 2°C / 65% RH ± 5%
- Accelerated: 40°C ± 2°C / 75% RH ± 5%
- Refrigerated: 5°C ± 3°C
- Frozen storage where appropriate
- Photostability per ICH Q1B Option 2
Details
Continuously monitored, fully documented.
Every chamber is on a 24/7 monitoring system with alarms for excursions, and every excursion is investigated and documented under our QMS. Calibration, mapping, and IQ/OQ/PQ records are kept on file and available for client and regulator audit.
- Continuous temperature and humidity logging with audit trail
- Annual mapping and ongoing calibration of all chambers
- Excursion investigation and CAPA workflow built into the QMS
- Pull schedules aligned to ICH timepoints (1, 3, 6, 9, 12, 18, 24, 36 months)
- Stability-indicating assays for potency and degradation products
- Final stability reports formatted for regulatory submission
Need shelf-life data on a product?
Tell us about the formulation and what you need it for, whether that's registration support, beyond-use justification, or ongoing surveillance, and we'll scope a program.
Contact VictoGen Pharma
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