Stability Study Requirements
This article contains the Stability Study requirements Across Major Regulatory Agencies
Stability Study Requirements Across Major Regulatory Agencies
1. USFDA for USA
Guideline Reference : ICH Q1A(R2)
Conditions:
Long-term: 25°C ± 2°C / 60% RH ± 5% RH (12 months)
Accelerated: 40°C ± 2°C / 75% RH ± 5% RH (6 months)
Intermediate (if required): 30°C ± 2°C / 65% RH ± 5% RH (6 months)
Additional: In-use, photostability (ICH Q1B), post-approval stability.
2. EMA for Europe :
Guideline reference : ICH Q1A(R2), Climatic Zone II.
Conditions:
Long-term: 25°C ± 2°C / 60% RH ± 5% RH (12 months)
Accelerated: 40°C ± 2°C / 75% RH ± 5% RH (6 months)
Intermediate (if required): 30°C ± 2°C / 65% RH ± 5% RH (6 months)
Additional: Bracketing & matrixing allowed, in-use stability required for liquids/injectables.
3. TGA for Australia :
Guideline for Reference : ICH Q1A(R2), Climatic Zone II.
Conditions:
Long-term: 25°C ± 2°C / 60% RH ± 5% RH (12 months)
Accelerated: 40°C ± 2°C / 75% RH ± 5% RH (6 months)
Intermediate (if required): 30°C ± 2°C / 65% RH ± 5% RH (6 months)
Additional: 30°C/65% RH for tropical regions.
4. MHRA for UK :
Guidelines: Follows EMA/ICH Q1A(R2).
Additional: May require extra data on degradation products.
5. WHO for Global Prequalification :
Covers Climatic Zones II-IVb:
Zone II: 25°C / 60% RH (12 months)
Zone III: 30°C / 35% RH (12 months)
Zone IVa: 30°C / 65% RH (12 months)
Zone IVb: 30°C / 75% RH (12 months)
Bracketing & Matrixing: Allowed.
6. ANVISA for Brazil :
Climatic Zone: IVb (hot & very humid).
Conditions:
Long-term: 30°C / 75% RH (12 months)
Accelerated: 40°C / 75% RH (6 months)
Additional: Photostability, post-approval stability.
7. CDSCO for India :
Climatic Zone: IVb.
Conditions:
Long-term: 30°C / 75% RH (12 months)
Accelerated: 40°C / 75% RH (6 months)
Additional: Real-time stability required for domestic approval, 5°C stability for sensitive products.
8. NMPA for China :
Climatic Zone: Mostly Zone II, but some areas require Zone IV conditions.
Conditions:
Long-term: 25°C ± 2°C / 60% RH ± 5% RH (12 months)
Accelerated: 40°C ± 2°C / 75% RH ± 5% RH (6 months)
Intermediate (if required): 30°C ± 2°C / 65% RH ± 5% RH (6 months)
Additional: China-specific studies, photostability.
9. PMDA for Japan :
Guidelines: ICH Q1A(R2), Climatic Zone II.
Conditions:
Long-term: 25°C ± 2°C / 60% RH ± 5% RH (12 months)
Accelerated: 40°C ± 2°C / 75% RH ± 5% RH (6 months)
Intermediate (if required): 30°C ± 2°C / 65% RH ± 5% RH (6 months)
Additional: Stability at lower temperatures for biologics.
10. GCC for Saudi Arabia, UAE, etc.
Climatic Zone: IVb.
Conditions:
Long-term: 30°C / 75% RH (12 months)
Accelerated: 40°C / 75% RH (6 months)
Additional: Photostability, in-use stability for multi-dose formulations.
In short can be say :
ICH Q1A(R2) is widely accepted (USFDA, EMA, TGA, PMDA).
Tropical & humid regions (India, Brazil, GCC) require Zone IVb studies (30°C/75% RH).
Photostability, in-use, and post-approval stability vary by region.
