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.
Pharmaceutical stability testing for clinical and regulatory programs
PharmSky provides ICH stability services for pharmaceutical, biotech and life sciences companies that need reliable data to support product development, clinical trials, registration submissions and post-approval commitments. Our programs are designed to assess how drug substances, excipients and finished drug products perform over time under controlled environmental conditions.
Effective stability testing supports critical decisions around shelf life, storage requirements, packaging suitability, transport conditions and labelling. PharmSky can design and manage the stability studies that sponsors need across early development, clinical manufacturing, registration and ongoing surveillance, with testing aligned to the product’s dosage form, risk profile and regulatory pathway.
Our stability chamber services include controlled storage under long-term, refrigerated, frozen and accelerated conditions. Long term stability studies can help demonstrate product performance over the intended shelf life, while accelerated stability studies provide earlier insight into degradation pathways, formulation robustness and potential storage sensitivities.
PharmSky’s GMP stability testing capability is supported by qualified chambers, monitored storage conditions, analytical testing expertise and practical program management. We can assist with protocol preparation, sample pull schedules, method selection, physical and chemical testing, microbiological assessment where required, trend evaluation and data package preparation.
By integrating ICH stability testing with analytical services, formulation development, GMP storage and clinical trial manufacturing, PharmSky helps sponsors generate stability data that is scientifically meaningful, traceable and suitable for CMC decision-making. Whether you need a focused feasibility study, registration-enabling stability program or ongoing surveillance testing, our team can support a clear and compliant stability strategy.
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.
