ICH Stability Testing and Storage
PharmSky can perform stability studies according to ICH guidelines to monitor the physical, chemical, biological, and microbiological attributes of products stored under accelerated and real time conditions over a defined period. This data is used to make decisions on material storage conditions, shelf life and labelling requirements and forms a critical component of regulatory submission documentation both before and after registration.
Key Components of Our ICH Stability Testing
PharmSky offers a comprehensive set of GMP stability programs that comply with ICH requirements, including:
- Protocol preparation and program management
- Stability sample storage and management
- Stabililty testing for clinical, registration, and surveillance purposes
- Photostability and stress testing
- Extractables and leachables testing
Stability studies are required at various stages throughout a products life cycle, including:
ICH Stability Guidelines
Pharmsky follows the Stability Testing of New Drug Substances and Products Q1A(R2) ICH guidelines.
Storage Conditions
Our GMP storage chambers have been qualified in alignment with regulatory requirements and are continuously monitored to ensure they stay within required limits. Stability programs can be undertaken under the following storage conditions.
- -20°C ± 5°C
- 5°C ± 3°C
- 25°C ± 2°C / 60 ± 5% RH
- 40°C ± 2°C / 75 ± 5% RH
Following the conclusion of a trial, storage of samples can continue for as long as required.
Stability Testing Types
Stability testing of drug substances, excipients, and drug products for clinical, registration, and surveillance purposes.
GMP-Compliant Storage and Testing Facilities
Pharmsky has a TGA-certified analytical laboratory, strictly following all the GMP testing guidelines and adhering GMP storage requirements.
Custom Stability Studies for Unique Needs
We work closely with our clients to tailor the studies to meet specific needs involving customizing aspects such as temperature, humidity, light exposure, and testing intervals based on product characteristics and regulatory requirements.
Why Choose PharmSky To Partner With?
PharmSky’s scientists bring decades of expertise to our clients. Combining this experience with our clients’ insights and our deep understanding of ICH Stability Testing and Storage services, we create safe and effective formulations that maximise the clinical and commercial potential of their products.
We embrace challenges, leveraging the diverse backgrounds of our staff to explore solutions others might overlook.
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Frequently Asked Questions
ICH stability testing refers to the guidelines set by the International Council for Harmonisation (ICH) for assessing the stability of pharmaceutical products. This type of testing helps to determine how the quality of a drug substance or product varies with time under the influence of environmental factors like temperature, humidity, and light. Stability testing ensures that drugs maintain their quality, safety, and efficacy throughout their shelf life.
The ICH defines stability zones to guide pharmaceutical companies in testing drug stability under various environmental conditions. These zones correspond to different climates worldwide and help ensure that drugs remain effective and safe under the temperature and humidity typical of their intended markets. There are four main ICH stability zones, each with specific temperature and humidity requirements for testing:
- -20°C ± 5°C
- 5°C ± 3°C
- 25°C ± 2°C / 60 ± 5% RH
- 40°C ± 2°C / 75 ± 5% RH
The ICH plays a crucial role in supporting regulatory submissions by creating guidelines that harmonize and streamline the requirements for drug development and registration across major regulatory regions, including the US, EU, and Japan. This reduces redundancy, speeds up the approval process, and increases consistency in drug safety, efficacy, and quality.
