ICH Stability Testing
ICH Q1A(R2) requires pharmaceutical manufacturers to establish a product’s shelf life and storage conditions. These studies must demonstrate that pharmaceutical products maintain its quality, safety, and efficacy throughout the claimed shelf life. While regulatory agencies expect real-time stability data, they also allow manufacturers to go to market with accelerated stability results from studies conducted under ICH-defined conditions.
PCL provides ICH-compliant accelerated and long-term stability testing designed to evaluate product performance over time in a shortened timeline. Accelerated stability results can be used to support shelf-life claims while real-time stability studies are performed.
Industry Application
Accelerated ICH stability testing provides a framework for developing stability protocols that estimate long-term product performance. These studies expose drug substances or drug products to elevated temperature and humidity conditions for a defined period to simulate the effects of extended real-time storage. For example, conditions such as 40°C/75% RH can provide early insight into product stability long before full real-time data is available.
If pharmaceutical companies were required to wait for complete real-time stability data before proceeding with regulatory submissions, the development and availability of new therapies would slow significantly. To support timely market access, global regulatory authorities allow accelerated stability data to be used, provided that real-time stability studies continue in parallel to confirm the accelerated findings.
How PCL Fulfills Your ICH Stability Needs
- Author protocols
- Provides chamber storage
- Supports lot release, on-going stability, or documentation
ICH Stability Testing
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Frequently Asked Questions
What is ICH stability testing?
ICH stability testing involves exposing drug substances or drug products to specific temperature and humidity conditions outlined in the ICH guidelines.
Why is stability testing required for pharmaceuticals?
Regulatory bodies require stability data to ensure that pharmaceutical products remain safe and effective throughout their intended shelf life.
What are the standard ICH stability conditions?
Common ICH conditions include:
Long-Term (12 months minimum, often 24 – 36 months): 25°C/60% RH or 30°C/65% RH
Intermediate (6 months): 30°C/65% RH
Accelerated (6 months): 40°C/75% RH