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OVERVIEW
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STABILITY STORAGE & TESTING
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| We support your projects |
Clinical trials |
BLAs |
NDA |
IND |
ANDA |
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We have expanded our state–of–the–art cGMP stability storage facilities to include
even more walk–in and reach–in validated environmental chambers set to various temperatures
and humidity conditions — all in accordance with ICH guidelines. The ongoing expansion, along with
our renowned commitment to outstanding project management, further enhances Irvine’s position as an
industry leader in stability programs.
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For the quality control and security your projects demand, all cGMP validated environmental chambers
and our photostability chambers are monitored 24 hours a day by a computer-based Environmental
Monitoring System. Our walk–in, reach–in, UV–visible and fluorescent photostability
chambers are supported by back-up chambers, a reserve generator and an electronic notification system.
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We have the latest Laboratory Information Management System (LIMS) to ensure the highest compliance.
Our LIMS is fully capable of complex trend analysis. The system accommodates sophisticated sample
management and allows the Stability Department to generate cumulative reports.
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At Irvine, our mission is to provide our clients with outsourcing solutions that make their drug
development priorities possible.
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