ICH Stability Testing & Storage Testing
Stability Storage and Testing
Vici Health Sciences offers stability storage and testing as stand-alone services or as part of a drug development program.
The FDA and ICH publish many guidelines related to product shelf life dating and stability studies. Per regulation, all clinical trial material and commercial pharmaceutical products must have an established shelf life. This is done by performing controlled ICH stability studies. Vici is well versed in all of these guidelines and has real world experience working with the FDA in establishing shelf life for a variety of products. As your end-to-end R&D partner, Vici can help perform all stability studies and guide you through the requirements at each stage of your program.
We have a variety of chambers to support all your stability study needs:
- Long-term testing: 25°C ± 2°C/60% RH ± 5% RH
- Intermediate testing: 30°C ± 2°C/65% RH ± 5% RH
- Accelerated testing: 40°C ± 2°C/75% RH ± 5% RH
- Refrigerator: 5°C ± 3°C
- Freezer: 20°C ± 5°C
Our chambers are constantly monitored and maintained under strict QA supervision.
Vici is licensed to store DEA Schedule I-V drug substances and drug products in our stability chamber.
We are well versed in the various requirements for stability testing in the pharmaceutical industry, including:
- Studying stability or increasing shelf life as part of R&D drug development
- Supporting stability for filing IND
- Supporting stability for phase 1, phase 2, or phase 2 clinical trials
- Supporting stability for tech transfers or manufacturing process scale-up and validation
- Supporting stability for commercial products